Regulatory Affairs Project Manager

Role - Project Manager- Regulatory Affairs (Onsite)

Primary Location: Bothell, WA, USA

Domain - Medical Device Regulatory Affairs.

Must have Skills –

Top 4 Must-Have Skills

• Global Regulatory Affairs Experience (8+ years)
• Product Registrations, Re-registrations & Renewals (Global Markets)
• Regulatory Dossier Compilation & Submission Management
• LATAM Regulatory Experience, preferably INVIMA

Role and Responsibilities:

• Lead global registration, re-registration, renewal, and lifecycle management activities across international markets.
• Establish and maintain a complete, well-organized, and submission-ready regulatory documentation repository to support global market registrations.
• Coordinate and execute pre-launch variations, renewals, amendments, and regulatory compliance activities.
• Review, compile, and dispatch high-quality regulatory dossiers to ensure successful first-cycle reviews by health authorities.
• Manage regulatory deficiencies, agency queries, and affiliate requests, ensuring timely and accurate responses.
• Collaborate with cross-functional teams (R&D, Quality, Supply Chain, Manufacturing, Marketing, Legal, and Affiliates) to support product registrations and launches.
• Monitor project plans, timelines, regulatory milestones, risks, and launch readiness;
  provide regular status updates to stakeholders.
• Maintain accuracy of regulatory databases, document management systems, and submission trackers.
• Act as the primary regulatory project contact for global stakeholders, affiliates, and regulatory agencies.

Education & Experience:

• Bachelor’s degree in pharmacy, Life Sciences, Chemistry, Biotechnology, Regulatory Affairs, or a related scientific discipline.
• 8+ years of Regulatory Affairs experience in healthcare, consumer healthcare, oral care, cosmetics, medical devices, or related industries.
• Proven experience managing global product registrations, renewals, and re-registration projects.
• Experience leading regulatory remediation, gap closure, registration recovery, or compliance-driven market continuity programs.
• Experience managing registrations, renewals, or re-registrations with INVIMA and other LATAM regulatory authorities preferred.

Skills:

• Experience in global regulatory requirements, dossier compilation, and new product registration processes.
• Excellent project management skills with the ability to manage multiple regulatory projects and timelines simultaneously.
• In-depth knowledge of technical documentation, quality compliance requirements, and current health authority guidance.
• Strong leadership, stakeholder management, negotiation, and cross-functional collaboration skills.
• Excellent problem-solving, risk management, and conflict resolution capabilities.
• Experience with document management systems to maintain submission-ready regulatory dossiers, track registrations and manage document lifecycles.