Regulatory Affairs Specialist

Employment Type: 6-Month Contract
Location: Fully Remote

We are seeking an experienced Regulatory Affairs Specialist to support the Biologics division of a global medical technology organization focused on musculoskeletal and orthopedic solutions.

This is a 6-month contract position providing coverage for a team member on maternity leave. The Regulatory Affairs Specialist will primarily support sustaining regulatory activities and product lifecycle management for biologics and human tissue-based products, while also assisting with other product portfolios as needed.

This is not a traditional medical device-only Regulatory Affairs position. The ideal candidate will bring direct experience working with biologics, human tissue products, HCT/Ps, orthobiologics, bone grafts, allografts, or similar human-derived products and understand the regulatory requirements associated with these products.

The position is fully remote, with required availability during core team hours of 9:00 AM-2:00 PM Pacific Time. The remaining 40 hours can be made up before or after times listed.

• Provide regulatory guidance to Quality, Manufacturing, Marketing, Product Development, and other cross-functional teams.
• Serve as the Regulatory Affairs representative on projects supporting biologics, human tissue-based products, and medical devices.
• Review design changes, engineering change orders, manufacturing/process changes, labeling changes, and other product modifications to determine potential regulatory impact.
• Assess whether proposed product or process changes require regulatory submissions, notifications, documentation updates, or other regulatory actions.
• Support sustaining regulatory activities throughout the product lifecycle.
• Provide regulatory guidance related to product labeling, promotional materials, and sales training materials.
• Prepare and submit regulatory filings for new products and changes to existing products as required.
• Support interactions with regulatory authorities and ensure regulatory activities are accurately and appropriately documented.
• Assist with the compilation and maintenance of technical files, design dossiers, and other regulatory documentation.
• Support new conformity requirements and regulatory documentation as products and regulations evolve.
• Collaborate with cross-functional team members on international registrations, renewals, and tenders as needed.
• Maintain current knowledge of regulations, policies, standards, and guidance issued by relevant regulatory authorities.
• Support compliance with applicable requirements for human cells, tissues, and cellular and tissue-based products (HCT/Ps).
• Perform additional Regulatory Affairs responsibilities as assigned.

• Bachelor's degree required.
• 3-5+ years of Regulatory Affairs experience within the medical device, biologics, human tissue, or related regulated industry.
• Direct experience with biologics and/or human tissue-based products is strongly required.
• Experience with one or more of the following is highly desirable:
• HCT/Ps
• Human tissue products
• Orthobiologics
• Bone grafts or allografts
• Regenerative medicine products
• Blood, human cell, or tissue-based products
• Knowledge of applicable HCT/P requirements, including 21 CFR Part 1271, is highly preferred.
• Experience performing regulatory assessments of design changes, engineering changes, manufacturing changes, or product modifications.
• Demonstrated ability to prepare regulatory documentation suitable for submission to government or regulatory agencies.
• Strong written and verbal communication skills.
• Ability to effectively collaborate with Quality, Manufacturing, Engineering/Product Development, Marketing, and other disciplines.
• Strong organizational skills with the ability to prioritize assignments and meet deadlines.
• Ability to independently manage regulatory projects from initiation through completion.

For California Applicants:

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO) , and the California Fair Chance Act (CFCA).

This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.

Here at Medix, we are dedicated to providing workforce solutions to clients throughout multiple industries. We have been named among the Best and Brightest Companies to Work For in the Nation for two consecutive years. Medix has also been ranked as one of the fastest growing companies by Inc. Magazine.

Our commitment to our core purpose of positively impacting 20,000 lives affects not only the way we interact with our clients and talent, but also with our co-workers! The goal is lofty, but it is made attainable through the hard work and dedication of our teams and their willingness to lock arms together. Are you ready to lock arms with us?