RA Senior Specialist

Lead the regulatory path for cutting-edge health and medical products and make a meaningful impact on market access across the US.

R&D Partners is seeking a Regulatory Affairs Senior Specialist to join a dynamic team in the medical technology and devices industry. This role focuses on strategic regulatory delivery, commercial partnership, regulatory intelligence, risk management, and continuous improvement. The ideal candidate will have strong expertise in FDA regulations and experience across multiple regulated product sectors.

Applicants must have legal authorization to work in the United States.

Responsibilities:

• Strategic Regulatory Delivery: Develop and execute regulatory strategies for efficient market entry of IVDs, dietary supplements, cosmetics, and consumer health products, with a focus on the US market.
• Lead preparation and submission of regulatory dossiers, including FDA 510(k)s, cosmetic documentation, dietary supplement notifications, and international product registrations.
• Maintain product registrations throughout their lifecycle to ensure compliance.
• Commercial Partnership: Collaborate with Commercial and Product teams from concept through launch, providing practical regulatory advice to support informed business decisions.
• Identify compliant claims and positioning opportunities to drive product innovation.
• Regulatory Intelligence: Monitor emerging FDA regulations and enforcement trends across medical devices, IVDs, dietary supplements, cosmetics, and OTC products.
• Translate regulatory changes into actionable business recommendations.
• Risk Management: Perform regulatory risk assessments for new products and escalate significant compliance risks with mitigation plans.
• Support regulatory due diligence for new suppliers and products.
• Continuous Improvement: Contribute to the development of an integrated global QMS and identify opportunities to streamline regulatory processes.
• Improve submission quality and reduce approval timelines.
• Governance Reporting: Act as the primary US regulatory representative, providing visibility into regulatory activities, risks, and opportunities.
• Develop dashboards and KPIs to monitor product registrations, submission timelines, and compliance performance.
• Prepare concise monthly reports summarizing regulatory performance and emerging risks.

Key Skills and Requirements:

• Minimum of 3 years of experience in Regulatory Affairs within regulated product sectors such as medical devices, IVDs, dietary supplements, cosmetics, consumer healthcare, or pharmaceuticals.
• Strong knowledge of US FDA regulatory requirements, with expertise in one or more areas: medical devices, IVDs, dietary supplements, cosmetics, or OTC healthcare products.
• Proven ability to develop regulatory strategies that support successful product commercialization.
• Skilled in interpreting complex regulations and applying pragmatic, risk-based solutions.
• Experience working cross-functionally with Commercial, Product Development, Marketing, Supply Chain, and Quality teams.
• Excellent project management skills with the ability to manage multiple product launches simultaneously.

For more information, please contact Syem Mannan.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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