Waltham, Massachusetts, United States · Hybrid
$109k–$183k/yr
PURPOSE AND SCOPE: Develops regulatory strategies for assigned products/product lines. Prepares regulatory submissions required to market new or modified medical devices in the domestic and international clinical markets…
Skills: Regulatory Strategy, FDA Submissions, 510(k), PMA, IDE
Waltham, Massachusetts, United States · On-site
$151k–$170k/yr
Senior Scientist - Genome Editing, Genomic Sciences and Target Discovery Job Description: We are seeking an enthusiastic and highly motivated Senior Scientist to join the Genomic Sciences and Target Discovery team within…
Skills: CRISPR/Cas9, CRISPRa, CRISPRi, Functional Genomics, In Vivo Delivery
Waltham, Massachusetts, United States · On-site
$131k–$218k/yr
At Stewart, we know that success begins with great people. As a Stewart employee, you’ll be joining a company that was named a 2024-2025 Best Company to Work For by U.S. News & World Report, and a 2025 Top Workplace by U…
Skills: Title Underwriting, Risk Analysis, Legal Research, Title Insurance, Massachusetts Real Estate Law
Waltham, Massachusetts, United States · Hybrid
$250k–$320k/yr
Reporting to the EVP, Communications and Corporate Affairs, the VP, Communications Business Partner-Care Enablement is responsible for developing and executing a comprehensive, integrated communications strategy that adv…
Skills: Strategic Communications, Crisis Management, Executive Advisory, Employee Engagement, Public Relations
Waltham, Massachusetts, United States · On-site
$190k–$260k/yr
ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologi…
Skills: Quality Systems Leadership, Compliance Management, Digital Transformation, GxP Regulations, Business System Ownership
Waltham, Massachusetts, United States · Hybrid
$85k–$106k/yr
About us At National Grid, we keep people connected and society moving. As the energy landscape evolves, we are strengthening how we build talent, develop capability, and drive performance across the organization. Our fo…
Skills: Project Management, Learning And Development, Learning Design, Stakeholder Engagement, Program Coordination
Waltham, Massachusetts, United States · On-site
$23/hr–$25/hr
Join the Associated Home Care Team! Location: Multiple locations across Massachusetts Company: Associated Home Care Job Type: Full-Time, Part-Time, or Per Diem Job Code: AHC2000 About Us At Associated Home Care, our care…
Skills: Personal Care, Light Housekeeping, Meal Preparation, Mobility Support, Incontinence Care
Waltham, Massachusetts, United States · On-site
$26/hr–$29/hr
Job Description The Culinary Enablement is responsible for aiding the culinary team with administrative tasks including data entry and analyzing data in Galley. Interacts with guests, visitors, and employees in a profess…
Skills: Data Entry, Data Analysis, Microsoft Excel, Microsoft Outlook, Microsoft Word
Waltham, Massachusetts, United States · Hybrid
$71k–$89k/yr
About us At National Grid, we keep people connected and society moving. As the energy landscape evolves, we are strengthening how we build talent, develop capability, and drive performance across the organization. Our fo…
Skills: Learning Design, Program Management, Stakeholder Engagement, Performance Management, Internal Communications
Waltham, Massachusetts, United States · On-site
$142k–$269k/yr
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: Analytical Development, HPLC, Capillary Electrophoresis, Biologics, Method Development
Waltham, Massachusetts, United States · On-site
Welcome to Pyramid Global Hospitality, where people come first. As a company that values its employees, Pyramid Global Hospitality is dedicated to creating a supportive and inclusive work environment that fosters diversi…
Skills: Customer Service, Order Taking, Menu Knowledge, Upselling, Communication Skills
Waltham, Massachusetts, United States · On-site
$35/hr–$50/hr
Shift: Monday through Friday, 8:00 AM - 4:30 PM Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business …
Skills: HPLC, GC, LC-MS, FTIR, DD-PCR
Waltham, Massachusetts, United States · On-site
$161k–$305k/yr
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a r…
Skills: Clinical Pharmacology, PK/PD, Pharmacometrics, Drug Development, Regulatory Filings
Waltham, Massachusetts, United States · On-site
$38/hr–$52/hr
ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologi…
Skills: cGMP Manufacturing, Aseptic Processing, Cell Isolation, Upstream Processing, Downstream Processing
Waltham, Massachusetts, United States · On-site
$290k–$323k/yr
Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific …
Skills: Regulatory affairs, CMC, Global regulatory submissions, IND, BLA
Waltham, Massachusetts, United States · On-site
$40/hr–$50/hr
Are you looking to be an integral part of a thriving organization focused on sustainable remodeling? Looking for a workplace that aligns with your values and is committed to lifetime learning? Join the team at steveworks…
Skills: Residential Remodeling, Carpentry, Project Management, Client Communication, Subcontractor Scheduling
Waltham, Massachusetts, United States · Hybrid
$70k–$85k/yr
About demandDrive: demandDrive is a growth-focused go-to-market agency that helps B2B organizations accelerate pipeline and revenue through integrated sales, marketing, and revenue operations solutions. We partner with c…
Skills: Google Ads, LinkedIn Campaign Manager, 6sense, ABM Campaigns, Google Analytics 4
Waltham, Massachusetts, United States · On-site
$212k–$235k/yr
Company Overview: Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company focused on developing innovative solutions for patients and healthcare providers in the fields of Cr…
Skills: Quality Assurance, GMP Compliance, Strategic Leadership, Product Lifecycle Management, Regulatory Affairs
Chicago, Illinois, United States · Remote OK
$105k–$175k/yr
Company Description Curinos empowers financial institutions to put customers at center of every decision. Our AI-first platform transforms proprietary data, advanced analytics and deep financial services expertise into t…
Skills: Data Analytics, Client Relationship Management, Quantitative Analysis, Project Management, Strategic Planning
Waltham, Massachusetts, United States · On-site
$22/hr–$23/hr
Description Objective of Position: Balance and close out the financial transactions for the day. Provide all hotel guests with courteous and efficient service to maximize guest satisfaction and ensure their return. Areas…
Skills: Financial Balancing, Guest Services, Property Management System, Credit Card Settlement, Audit Reporting
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Develops and manages regulatory strategies and submissions for medical devices to ensure domestic and international market access. Oversees project timelines, prepares FDA filings, and ensures ongoing compliance with regulatory policies.
Requires a Bachelor's degree and at least 8 years of related submission experience, specifically with 510(k) filings. Candidates must demonstrate the ability to manage multiple projects independently and communicate effectively with cross-functional teams.
Develops regulatory strategies for assigned products/product lines. Prepares regulatory submissions required to market new or modified medical devices in the domestic and international clinical markets. Develops and maintains procedures and systems designed to ensure the product development process addresses all regulatory requirements as well as the objectives of the business.
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
10 – 15% domestic and international travel as required.
The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies.
Annual Rate: $109000 - $183000
Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance."
Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases. We aim to create a future worth living for chronically and critically ill patients – worldwide and every day. Thanks to our decades of experience in dialysis, our innovative research and our value-based care approach, we can help them to enjoy the very best quality of life. Our portfolio encompasses a comprehensive range of high-quality health care products and services as well as various dialysis treatment options for both in-center and home dialysis that are individually tailored to our patients’ needs.
Offices: Else-Kröner-Strasse 1, Bad Homburg, Frankfurt 61352, DE
