Healthcare Jobs in Cleveland, OH (Now Hiring) — 1,281 open — Page 36
Cleveland Diagnostics
Senior Director of Regulatory Affairs
Cleveland, Ohio, United States · Hybrid
$125k–$225k/yr
Senior+$125M raised
Job Title: Senior Director of Regulatory Affairs Reports to: Chief Medical Officer Job Overview The Senior Director of Regulatory Affairs will provide strategic and operational leadership for regulatory affairs activitie…
Skills: Regulatory affairs, FDA submissions, PMA, 510(k), IVD
RN1 with BSN Care Coord., Peds Hematology/Onc - Main Campus
Cleveland, Ohio, United States · On-site
Mid level$15M raised
A Brief Overview Provides safe efficient age specific nursing care to patients/families using the nursing process in order to assist them to attain, maintain, regain, and sustain optimal health status. What You Will DoIm…
Offering $3,000 Sign-On Bonus! MedVet is a fast-growing Emergency and Specialty provider with practices nationwide. We help our patients receive advanced medical treatments and innovations. Things like chemotherapy and r…
We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate…
SALARY The salary range for this position is $25 - $40 per hour. QUALIFICATIONS Education: Minimum Bachelor’s degree in Social Work or Counseling required.Licensure: Valid Ohio LSW, LPC or MFT required. LISW, LPCC or IMF…
Skills: Clinical assessment, Case management, Crisis intervention, Mental health screening, Safety planning
At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, ev…
Skills: Histology, Laboratory accessioning, Data entry, Specimen processing, Problem solving
We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate…
MedVet is a fast-growing Emergency and Specialty provider with practices nationwide. We help our patients receive advanced medical treatments and innovations. Things like chemotherapy and radiation, cardiac ablations, tr…
At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, ev…
We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate…
At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, ev…
Skills: Respiratory therapy, Pulmonary function testing, Blood gas analysis, Patient education, Quality improvement
Overview In this role, you’ll be an important member of the clinical team, working alongside GPs and other Specialty Clinicians dedicated to serving patients. You’ll be supporting many sides of the practice, greeting and…
Overview Schedule: Full Time / 40 hours a week / M-F 8a-5p Location: Cleveland, OH (4660 Hinckley Industrial Pkwy) Are you ready to take your career to new heights? At Concentra, you will be a vital member of our patient…
Overview Schedule: Full Time / 40 hours a week / M-F 8a-5p Location: Cleveland, OH (4660 Hinckley Industrial Pkwy) Are you ready to take your career to new heights? At Concentra, you will be a vital member of our patient…
Skills: Radiologic procedures, Patient care, Phlebotomy, Vital signs, Drug testing
Summary The counselor, art therapy or social work intern will be responsible for shadowing and providing psychotherapy services including mental health assessment, treatment planning, individual psychotherapy sessions an…
Skills: Mental health assessment, Psychotherapy, Treatment planning, Group psychotherapy, Psychoeducational health and wellness
We’re seeking a full-time Professional I, Behavioral Health Specialist/Case Manager to provide individualized support, behavioral healthcare and non-healthcare services to clients who are overcoming and/or in the r…
Skills: Case management, Behavioral health support, Therapeutic relationship building, Care plan coordination, Client assessment
Seidman Cancer Center - Ambulatory Malignant Hematology/Stem Cell Transplant
Cleveland, Ohio, United States · On-site
Entry level$15M raised
Seeking an Advanced Practice Provider to join the outpatient malignant hematology and stem cell transplant team at UH Cleveland Medical Center. The schedule is 5 8 hr. days or 4 10's and every 9th weekend. APP experience…
Skills: Patient assessment, Diagnosis, Care planning, Interdisciplinary collaboration, Leadership
Smile Brands Inc.
Expanded Function Dental Assistant
Cleveland, Ohio, United States · On-site
Entry level
Overview In this role, you’ll be an important member of the clinical team, working alongside GPs and other Specialty Clinicians dedicated to serving patients. You’ll be supporting many sides of the practice, …
Advanced Practice Provider - Interventional Radiology
Cleveland, Ohio, United States · On-site
Entry level$15M raised
To Heal. To Teach. To Discover. At University Hospitals, this is more than just our mission. These words embody the opportunities available to the many world-class doctors, nurses, health care professionals, and support …
Skills: Interventional Radiology, Patient Assessment, Diagnosis, Care Planning, Interdisciplinary Collaboration
$23.50/hour PLUS first year bonus: $5,000. After 1st year targeted annual bonus increases to $10,000. No medical experience required. We will train you! Check out this video to see what a day in the life as a Mobile Heal…
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$125k–$225k/yr
Full-time
Medical insurance, Dental insurance, Vision insurance, Group term life insurance, Short term disability, Long term disability
Posted 33d ago
~40 hrs/week
Responsibilities
The Senior Director of Regulatory Affairs will lead global regulatory strategies for IVD and LDT products throughout the entire product lifecycle. This role involves managing FDA submissions, ensuring post-market compliance, and providing strategic guidance to cross-functional teams.
Requirements
Candidates must have at least 10 years of progressive regulatory affairs experience within the medical device or diagnostics industry. Significant experience with FDA-regulated IVD products and regulatory submission processes is required.
Full job description
Job Title: Senior Director of Regulatory Affairs
Reports to: Chief Medical Officer
Job Overview
The Senior Director of Regulatory Affairs will provide strategic and operational leadership for regulatory affairs activities supporting Cleveland Diagnostics’ in vitro diagnostic (IVD) and laboratory developed test (LDT) product portfolio, including tests/assays intended for early cancer detection and other clinical indications. This role will lead the development, execution, and maintenance of global regulatory strategies across the full product lifecycle, including pre-market submissions, post-market obligations, regulatory agency interactions, and ongoing compliance with applicable U.S. and international regulatory requirements.
The Senior Director will serve as a regulatory leader for FDA-regulated IVD products, including PMA, PMA supplement, 510(k), amendment, annual report, and post-approval submission activities, as well as international regulatory documentation, including IVDR Technical Documentation and other jurisdictional requirements where applicable. This position requires strong strategic judgment, integrity, deep knowledge of IVD and other regulatory pathways, excellent technical writing and review capabilities, and the ability to lead cross-functional teams through complex regulatory programs.
The role is expected to operate at both a strategic and hands-on level, providing executive-level regulatory guidance while ensuring high-quality execution of submissions, regulatory documentation, and compliance activities.
Essential Duties & Responsibilities
Regulatory Strategy and Leadership
Lead the development and execution of regulatory strategies for new and existing IVD and LDT products throughout the product lifecycle.
Serve as the company’s senior regulatory subject matter expert for U.S. FDA and applicable international regulatory requirements related to IVD and LDT products.
Provide strategic regulatory guidance to executive leadership, product development teams, clinical operations, medical affairs, quality assurance, manufacturing, legal/compliance, and commercial stakeholders.
Assess regulatory pathways, submission requirements, approval risks, and post-market obligations for new products, expanded indications, product modifications, and lifecycle management activities.
Translate regulatory requirements into actionable development, clinical, medical affairs, quality, manufacturing, and submission plans.
Anticipate regulatory risks and develop mitigation strategies to support timely product development, approval, launch, and post-market maintenance.
Lead interactions when appropriate with outside legal, regulatory, and statistical consultants.
Regulatory Submissions and Agency Interactions
Lead the planning, preparation, review, submission, and maintenance of regulatory submissions and related documentation, including PMAs, PMA supplements, amendments, annual reports, 510(k)s, FDA correspondence, and international regulatory dossiers.
Oversee preparation and maintenance of IVDR Technical Documentation and other international regulatory documentation, as applicable.
Lead or support interactions with FDA, Notified Bodies, and other regulatory authorities, including meeting requests, pre-submission activities, responses to questions, deficiency responses, and post-approval communications.
Ensure regulatory submissions are accurate, complete, scientifically sound, strategically positioned, and submitted in accordance with applicable timelines and requirements.
Provide senior-level review of technical, clinical, analytical, manufacturing, labeling, and quality documentation for regulatory consistency and compliance.
Product Lifecycle and Change Management
Lead regulatory assessment of product development activities, design changes, manufacturing changes, process changes, labeling changes, and clinical or analytical updates.
Determine appropriate regulatory reporting or submission requirements for product and process changes.
Partner with Quality Assurance, Manufacturing, IVD Test Development, Clinical Operations, and other functions to ensure changes are properly assessed, documented, and implemented in compliance with regulatory requirements.
Oversee maintenance of product approvals, listings, registrations, supplements, amendments, post-approval reports, and related regulatory records on a domestic and international basis.
Post-Market Regulatory Compliance
Provide leadership for post-market regulatory activities, including post-market surveillance, vigilance reporting, adverse event assessment, field action support, annual reporting, and regulatory record maintenance.
Ensure post-market regulatory obligations are identified, tracked, and fulfilled in accordance with FDA, IVDR, and other applicable requirements.
Support quality system activities related to complaints, CAPAs, nonconformances, audits, inspections, and regulatory reporting decisions.
Monitor evolving regulatory requirements, guidance documents, standards, and enforcement trends and communicate relevant implications to internal stakeholders.
Cross-Functional Collaboration and Organizational Leadership
Lead cross-functional regulatory planning and execution with Clinical Operations, Legal and Compliance, IVD Test Development, Quality, Manufacturing, Commercial, Medical Affairs, and external consultants.
Provide regulatory leadership for product development teams, clinical study teams, design control activities, and launch readiness planning.
Build, manage, and mentor regulatory affairs personnel, consultants, and vendors as needed.
Establish clear regulatory roles, timelines, deliverables, and accountability across internal and external teams.
Promote a culture of regulatory excellence, scientific rigor, documentation discipline, and compliance.
Regulatory Systems, Policies, and Documentation
Lead the development, implementation, and maintenance of regulatory policies, procedures, templates, regulatory intelligence processes, and submission standards.
Ensure regulatory documentation systems support accuracy, traceability, version control, and inspection readiness.
Oversee regulatory document management practices for large, complex technical files and submission packages.
Support continuous improvement of regulatory processes, tools, and templates to improve quality, efficiency, and compliance.
Other Duties
Represent Regulatory Affairs in internal leadership meetings, project governance discussions, audits, inspections, and external regulatory engagements.
Support business development, partnership, investor, or commercial activities by providing regulatory input as requested.
Participate as an integral member of the Cleveland Diagnostics Senior Leadership Team (SLT)
Perform other duties as assigned.
Qualifications/Requirements
Minimum of 10 years of progressive regulatory affairs experience in the medical device, diagnostics, or IVD industry.
Significant experience with FDA-regulated IVD products required.
Demonstrated leadership experience with FDA submissions, including PMAs, PMA supplements, amendments, annual reports, 510(k)s, pre-submissions, and responses to FDA questions.
Experience with blood-based diagnostics, oncology diagnostics, laboratory-developed tests, companion diagnostics, and early cancer detection products preferred.
Experience with IVDR Technical Documentation, Notified Body interactions, and international regulatory submissions preferred.
Prior experience leading regulatory strategy for product development, clinical validation, analytical validation, design changes, manufacturing changes, and post-market compliance.
Experience managing regulatory personnel, consultants, vendors, or cross-functional submission teams preferred.
Experience supporting FDA inspections, audits, quality system activities, complaint evaluations, vigilance reporting, or post-market surveillance preferred.
Knowledge, Skills, and Abilities
Deep working knowledge of applicable regulatory frameworks, including FDA medical device and IVD regulations, PMA requirements, 510(k) requirements, 21 CFR 820/QMSR, ISO 13485, CLIA, IVDR, and relevant FDA guidance documents.
Strong strategic judgment and ability to advise executive leadership on regulatory risks, options, timelines, and business implications.
Excellent technical writing, editing, and regulatory submission review skills.
Ability to critically assess scientific, clinical, analytical, quality, manufacturing, and technical documentation.
Strong leadership, communication, negotiation, and cross-functional collaboration skills.
Ability to manage multiple complex regulatory programs, competing priorities, and time-sensitive deliverables, and regulatory affairs program budgets/KPIs
Exceptional attention to detail and strong document management, version control, and regulatory records discipline.
Advanced proficiency with Microsoft Word & Excel, and complex document formatting, including templates, styles, tracked changes, tables of contents, cross-references, and large technical documents.
Ability to operate effectively in a growing, fast-paced organization with hands-on involvement as needed.
Physical Requirements
Offices are reachable by elevator; must be able to climb stairs in the event elevator access is unavailable. General office and HVAC noise & fluorescent and/or LED lighting
Ability to sit and/or stand and operate a computer and other technology-related equipment throughout the workday.
May occasionally enter laboratory or manufacturing areas and may be exposed to hazardous chemicals, biohazards, or related controlled environments, subject to applicable safety procedures.
Other Requirements
This may be a hybrid position however Cleveland area candidates are preferred
Occasional travel may be required for regulatory meetings, audits, inspections, conferences, partner meetings, or other business needs.
Must be able to maintain confidentiality of proprietary, clinical, regulatory, and business-sensitive information.
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Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics.
We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee’s well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.
Cleveland Diagnostics offers an extremely robust benefits package which includes:
100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
100% Employer-paid Dental & Vision for entire family
No cost for employee coverage for Group Term Life, Short & Long Term Disability
4% retirement contribution Employer match
Incentive Performance Plan & Stock Option Program & Commission program
Generous PTO plan & holiday program
Flexible work schedule & lucrative employee referral program
Salary may vary by work state/geographical region/territory
Easy to get to office location with newly built-out office space
Free coffee, snacks and other goodies all day long
Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company’s status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.
Cleveland Diagnostics is a cancer biotechnology company that is changing the shape of cancer detection
Industry
Biotechnology Research
Company size
51-200 employees
Founded
2013
Headquarters
Cleveland, Ohio
LinkedIn followers
5,314
Total funding
$125M
Cleveland Diagnostics has unlocked the diagnostic power of protein structure with its revolutionary IsoClear™ platform to develop novel diagnostics based on protein structure-based assessment.
Offices: 3615 Superior Avenue, Cleveland, Ohio 44114, US
How many Healthcare jobs are open in Cleveland, OH right now?
There are currently 1,281 open healthcare positions in Cleveland, OH listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Cleveland, OH?
Companies currently hiring include University Hospitals, Cleveland Clinic, The Centers, Hospice of the Western Reserve, CVS Health, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Cleveland, OH?
Yes — 123 of the 1281 open healthcare positions offer remote or hybrid work (42 remote, 81 hybrid).
How do I apply for Healthcare jobs in Cleveland, OH?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.