Role - Project Manager- Regulatory Affairs (Onsite)

Primary Location: Bothell, WA, USA

Domain - Medical Device Regulatory Affairs.

Must have Skills –

Top 4 Must-Have Skills

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.

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