Regulatory Affairs Project Manager

Regulatory Affairs Project Manager (RAPM)

Location: Onsite Monday–Thursday | Remote Friday (8:00 AM – 5:00 PM; occasional overtime)

Compensation: $62/hour

Duration: 1-year contract with potential for temp-to-hire

The Regulatory Affairs Project Manager (RAPM) is responsible for directing and coordinating all regulatory activities associated with global Legal Manufacturer (LM) transitions across the organization. This role oversees a defined 12-month program timeline, ensures cross‑functional alignment, and drives execution of regulatory deliverables required to implement LM changes, including global label updates and notified body/agency notifications.

The RAPM leads a focused project team and serves as the central point of coordination between Regulatory Affairs, Quality, Operations, Supply Chain, Labeling, Program Management, and regional regulatory partners. This position ensures LM change requirements are clearly understood, strategically planned, and executed in accordance with global regulatory expectations. All labeling updates must align with regulatory leadership direction and country‑specific requirements. This position requires on‑site presence four days per week.

• Lead the end‑to‑end regulatory workstream for Legal Manufacturer changes across a defined 12‑month program timeline.
• Oversee project planning, status tracking, and risk mitigation to ensure LM milestones are delivered on schedule.
• Conduct regular stand‑ups, cross‑team syncs, and leadership updates; document key decisions and maintain clear program visibility.
• Develop, communicate, and maintain regulatory strategies for LM transitions, including required submissions, notifications, and regulatory impact assessments.
• Identify regulatory risks and proactively recommend solutions to support timely global implementation.
• Ensure aligned execution of global label changes based on direction from the Regulatory Labeling Leader, including updates to artwork, symbols, addresses, and LM identifiers.
• Manage preparation, review, and submission of LM‑related regulatory documentation to global health authorities (e.g., amendments, change notifications, updated Technical Documentation).
• Coordinate responses to authority or notified body inquiries and ensure proper documentation and archiving.
• Build and maintain strong cross‑functional relationships to foster trust and alignment on LM change requirements.
• Act as the primary regulatory liaison for LM change activities with Operations, Labeling, Quality Engineering, Program Management, Regional RA, and other stakeholders.
• Clearly communicate regulatory expectations, label change requirements, and timeline impacts across teams.
• Lead and mentor a dedicated LM project team, guiding decision‑making through regulatory expertise and influence.
• Share best practices, regulatory insights, and program learnings with junior regulatory staff.
• Stay current with global regulatory requirements impacting LM changes, including EU MDR, FDA, ISO standards, and international regulations.
• Monitor regulatory developments that may affect LM labeling or legal entity obligations.
• Perform additional responsibilities as assigned by Management.

• Bachelor’s degree from a four‑year college/university with 7+ years of regulatory affairs experience within the medical device or regulated industry OR
• Master’s degree with 4+ years of regulatory affairs experience in medical devices or another regulated industry

• Experience with global regulatory frameworks, including FDA, MDR, and ISO standards
• Experience preparing and managing regulatory submissions such as 510(k), CE Technical Files, and Rest of World (ROW) submissions
• Experience with medical and/or dental devices
• Strong FDA regulatory experience
• ROW international regulatory experience

• Strong project management and cross‑functional leadership skills
• Ability to manage complex global regulatory programs with defined timelines
• Excellent communication and stakeholder engagement skills
• Proven ability to assess regulatory impact and mitigate risk
• Experience leading labeling changes and regulatory…