Senior Specialist Device Technical Regulatory

Responsibilities

• Lead regulatory strategies and compliance for medical devices and drug-device combination products.
• Collaborate with Global Device Development (GDD) to develop regulatory plans aligned with program timelines.
• Lead Device Program Teams (DPTs) in implementing strategies that ensure compliance with global regulations, legislations, and standards.
• Author and review critical regulatory submission documents, including NDA, ANDA, BLA, MAA, and NBOp applications.
• Provide expert guidance on FDA and EU regulations, design controls, and applicable ISO standards.
• Ensure timely communication of agency feedback and regulatory outcomes to management and program teams.

Requirements

• Bachelor's degree in a scientific or engineering discipline (Master's degree or higher is desirable).
• Extensive experience in the Medical Device or Drug-Device Combination Product industry.
• Demonstrable knowledge of global regulatory requirements, specifically 21 CFR 820 and MDR (EU) 2017/745.
• Proven experience with ISO 13485 and device design controls.
• Experience working within multi-disciplinary pharmaceutical development teams.
• Strong track record of leading teams through complex problem-solving regarding technical regulatory issues.
• Excellent written and verbal communication skills in English.

Benefits

• Competitive salary and bonus scheme.
• Excellent career progression opportunities.
• Work-life balance initiatives.
• Health insurance and pension schemes.

About the Company

McDermott Laboratories Limited is part of Viatris, a global healthcare company dedicated to providing access to high-quality medicines for approximately 1 billion patients annually. We bridge the gap between generics and brands to address healthcare needs holistically, empowering people worldwide to live healthier at every stage of life.