Warsaw, Indiana, United States · On-site
GENERAL SUMMARY: The Regulatory Affairs Specialist will act as regulatory representative on cross functional New Product Development teams. Following the Phase Gate process, the regulatory affairs specialist will work cl…
Skills: Regulatory Strategy, 510(k) Submissions, Technical Writing, Medical Device Regulations, Design History File
Warsaw, Indiana, United States · On-site
Position Summary The CNC Machinist I Produces machined parts by operating a computer numerical control (CNC) machine; maintaining quality and safety standards; keeping records; maintaining equipment and supplies. The rol…
Skills: CNC Machine Operation, Tooling Adjustment, Quality Inspection, Measuring Equipment, Preventative Maintenance
Warsaw, Indiana, United States · On-site
$63k–$94k/yr
ABOUT SLATE At Slate, we’re building safe, reliable vehicles that people can afford, personalize and love—and doing it here in the USA as part of our commitment to reindustrialization. The spirit of DIY and customization…
Skills: Windows 11 Troubleshooting, Endpoint Management, Microsoft 365, Entra ID, Azure Active Directory
Biomet Manufacturing CorpWarsaw, Indiana, United States · Hybrid
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet produc…
Skills: Operational Excellence, Lean Manufacturing, Six Sigma, Strategic Planning, Change Management
Zimmer, Inc.Warsaw, Indiana, United States · On-site
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet produc…
Skills: Quality Engineering, Project Management, Audit, Inspection, Corrective and Preventative Action
Warsaw, Indiana, United States · On-site
Quality Engineer I Position Summary The Quality Engineer I will interact with team members to ensure compliance and internal and external customer requirements are met, with focus on quality engineering. This will be acc…
Skills: Quality Engineering, FMEA, PPAP, CAPA, ISO 13485
Palm Beach Gardens, Florida, United States · Hybrid
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less in…
Skills: Analytical Reasoning, Cross-Functional Collaboration, Demand Forecasting, Demand Planning, Distribution Resource Planning (DRP)
Warsaw, Indiana, United States · On-site
ABOUT SLATE At Slate, we’re building safe, reliable vehicles that people can afford, personalize and love—and doing it here in the USA as part of our commitment to reindustrialization. The spirit of DIY and customization…
Skills: Material Flow, Inventory Management, Cycle Counting, PIV Operation, Receiving and Shipping
Warsaw, Indiana, United States · On-site
$20/hr–$23/hr
A. M. Castle & Co. has over 135 years of experience as a leader in the metals service center industry. We provide exceptional benefits, including but not limited to: medical, dental, vision, 401K match, paid time off, pa…
Skills: Routing, Transportation Management, Shipping Documentation, Customer Service, Carrier Relationship Management
Zimmer, Inc.Warsaw, Indiana, United States · On-site
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet produc…
Skills: Supply Chain Planning, Production Planning, Materials Planning, General Management, Analytical Tools
Warsaw, Indiana, United States · On-site
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less in…
Skills: Agile Manufacturing, Equipment Maintenance, Good Manufacturing Practices (GMP), OSHA Compliance, Plant Operations
Zimmer Production, Inc.Warsaw, Indiana, United States · On-site
Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the qual…
Skills: Leadership, Production Scheduling, FDA QSR Compliance, 5S Auditing, Layered Process Audits
Zimmer US, Inc.Warsaw, Indiana, United States · Remote OK
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet produc…
Skills: Sales Training, Orthopedic Sales, Workshop Leadership, Budget Management, Instructional Design
Warsaw, Indiana, United States · On-site
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices conti…
Skills: Production Leadership, FDA Compliance, Lean Manufacturing, Performance Management, Resource Planning
Biomet Manufacturing CorpWarsaw, Indiana, United States · On-site
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet produc…
Skills: Blueprint Reading, Geometric Dimensioning and Tolerancing, Microsoft Office Suite, Minitab, Process Validation
Zimmer, Inc.Warsaw, Indiana, United States · On-site
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet produc…
Skills: Manufacturing Management, Lean Manufacturing, Six Sigma, Budgeting, Quality System Compliance
Warsaw, Indiana, United States · On-site
Description We're seeking a Machine Operator to join our Team! Manufacturing plant; will be required to wear personal protective equipment per policy and may be requested to work overtime per production schedule. Qualifi…
Skills: Machine Operation, Quality Inspection, Measurement Tools, Material Mixing, Mathematical Calculations
Warsaw, Indiana, United States · On-site
Description Primary Responsibilities: 1. Responsible for the efficient operation of Flexaust machines 2. Tracking of pieces produced 3. Inspecting final products for quality 4. Work areas must be kept safe, clean, and or…
Skills: Machine Operation, Quality Inspection, Production Tracking, Safety Compliance, Tape Reading
Zimmer Production, Inc.Warsaw, Indiana, United States · On-site
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet produc…
Skills: Tool and Die Making, CNC Equipment, Metal Cutting, Grinding, Plastic Working
Zimmer Production, Inc.Warsaw, Indiana, United States · On-site
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet produc…
Skills: Tool and Die Making, CNC Equipment, Metal Cutting, Grinding, Plastic Working
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The Regulatory Affairs Specialist develops regulatory strategies and prepares submissions like 510(k) and Technical Files for new and modified medical devices. They collaborate with cross-functional teams to ensure product compliance with global standards and manage regulatory databases.
Candidates should possess a bachelor's degree and preferably at least 2 years of experience in medical device regulatory affairs. Strong technical writing skills and a fundamental understanding of medical device terminology and anatomy are required.
GENERAL SUMMARY: The Regulatory Affairs Specialist will act as regulatory representative on cross functional New Product Development teams. Following the Phase Gate process, the regulatory affairs specialist will work closely with each project team to develop regulatory strategies, testing requirements and other documentations to assure that regulatory submissions are prepared and cleared/approved to meet the company's product launch timelines for new and modified products.
ESSENTIAL FUNCTIONS:
• Work closely with each New Product Development team in developing the regulatory strategy for the new and modified products.
• Work closely with the product managers to understand the country’s registration needs and priorities and provide regulatory input to the product managers such as registration strategies, timeline, and costs.
• Work closely with engineering team on the testing requirements and support the development of verification and validation testing plan. Review engineering documentation under the design history file to ensure compliance with the standards, guidance, and regulatory requirements.
• Prepare regulatory submissions such as 510(k), Letter to File, Health Canada Submission, Technical Files, etc. for new and modified devices.
• Updates and maintains databases with required information and status for UDI, GUDID, licenses, approvals, renewals, and other required data to assure compliance with business and regulatory requirements.
• Review and approve product, supplier, and manufacturing changes for compliance with applicable regulations and applicable procedures. Work closely with Regulatory and Clinical Affairs team members to provide regulatory change assessments for each country/region where the products are registered.
• Work closely with Regulatory and Clinical Affairs team members in monitoring the impact of changing regulations of each country on submission requirements and strategies.
• Assign, review, revise and approve device labeling and marketing materials to ensure continued compliance with global regulations.
• Provide support in developing regulatory procedures when necessary.
• Provide regulatory input for product recalls and recall communications.
• Performs other duties as assigned.
SUPERVISORY RESPONSIBILITIES: There are no direct supervisory responsibilities for this position.
QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
• Demonstrate a fundamental understanding of medical device terminology, anatomy, regulations, standards and technical concepts
• Understanding of regulations and guidelines governing all phases of Medical Device development with guidance and supervision.
• Understanding new product development requirements and processes with guidance and supervision.
• Excellent technical writing and editing skills, verbal and written communication skills including presentation skills.
• Able to handle multiple tasks/projects and demonstrate flexibility in managing changing priorities.
• Able to work within deadlines as imposed by government regulations and internal guidelines.
• Able to take direction and work and solve problems both independently and as part of a team.
EDUCATION AND/OR EXPERIENCE: Requires a bachelor’s degree; advanced degree preferred. Minimum of 2 years’ experience in regulatory of medical devices is preferred.
LANGUAGE SKILLS: Ability to read and comprehend instructions, correspondence, and memos. Ability to prepare routine reports and correspondence. Ability to communicate effectively with customers, vendors and other employees of the organization. Requires excellent grammar and spelling.
MATHEMATICAL SKILLS: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent.
REASONING ABILITY: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
CERTIFICATES, LICENSES, REGISTRATIONS: Requires a valid driver’s license.
OTHER SKILLS AND ABILITIES: Requires the ability to operate a variety of standard office equipment, such as a computer and keyboard, calculator, fax, photocopier, telephone, cell phone, etc. Requires proficiency with Microsoft Word, Excel, Outlook and PowerPoint.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation will be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle or feel. The employee is frequently required to climb stairs, talk and hear. The employee is occasionally required to stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus.
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is that found in a normal office environment; noise levels during visits to other locations in the building may be moderate and occasionally loud. The employee occasionally performs work related to travel.
The above statement reflects the general details necessary to describe the principal functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.
Leading Innovation in Pediatric Orthopedics
OrthoPediatrics is Leading Innovation in Pediatric Orthopedics. We are the first company whose total focus is helping children with orthopaedic conditions and injuries by providing the surgeons who care for them with anatomically appropriate implants. Every day, we focus exclusively on advancing the field of pediatric orthopedics through the innovative development of state-of-the-art technologies, commitment to quality products, and industry-leading support and clinical education with our experienced team of experts. Our offering is continuing to expand as we strive to develop all of the necessary implants and instruments that a pediatric orthopedic surgeon needs to treat his/her patients, including: Long Bone Deformity Correction & Trauma, Scoliosis, and Sports Medicine/Soft Tissue Repair. On October 12, 2017, OrthoPediatrics became a publicly traded company on the Nasdaq - trading under the symbol "KIDS"! As we continue to grow, we are looking for talented professionals to join our cause! Visit our website to learn more about current openings, or submit a resume to [email protected]!
Offices: 2850 Frontier Drive, Warsaw, IN 46582, US
Based on 42 listings with disclosed salaries, most manufacturing jobs in Warsaw, IN pay between $65k–$168k per year. Individual offers vary with seniority, company size, and specialization.
There are currently 120 open manufacturing positions in Warsaw, IN listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Zimmer Biomet, Slate Auto, Johnson & Johnson Innovative Medicine, Avalign Technologies, Medtronic, among others. Browse the listings above to see every active employer.
Yes — 17 of the 120 open manufacturing positions offer remote or hybrid work (2 remote, 15 hybrid).
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.
