Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist (Global Diagnostics)
Location: Remote within the EU
Employment Type: Full‑time
Position Summary
The Senior Regulatory Affairs Specialist will support global regulatory activities for an innovative portfolio of diagnostic products, including advanced molecular and non‑invasive testing technologies. The role is responsible for contributing to global submissions, supporting product development activities, and providing regulatory interpretation to cross‑functional partners.
This position works closely with R&D teams, Quality, Clinical, and international regulatory colleagues to ensure compliance with global requirements and to help guide products through their development and lifecycle stages.
The Senior Specialist is expected to operate with a high level of independence while collaborating closely with senior regulatory leaders.
Key Responsibilities
Global Regulatory Support
- Prepare and support regulatory submissions for multiple international regions, including the EU, APAC, Middle East, Africa, India, and South America.
- Interpret international regulatory requirements and provide clear, actionable guidance to cross‑functional teams.
Product Development Support
- Partner with R&D teams (including US-based groups) to provide regulatory input on design, development, analytical validation, and clinical evidence needs.
- Explain regulatory expectations and support teams in understanding the rationale ("the why") behind global requirements.
Regulatory Documentation & Lifecycle Activities
- Contribute to the development and maintenance of technical documentation, including technical files, design dossiers, and post‑market documents.
- Support lifecycle submissions, including renewals, variations, updates, and responses to authority queries.
Compliance & Regulatory Intelligence
- Monitor and interpret global regulatory changes relevant to diagnostic and IVD products.
- Support adherence to IVDR, international IVD regulations, and applicable country‑specific requirements.
- Maintain accurate and compliant regulatory records.
Cross‑Functional Collaboration
- Work collaboratively with Quality, Clinical, Program Management, and regional regulatory colleagues.
- Communicate regulatory timelines, data needs, and submission requirements to internal teams.
- Participate in cross‑functional meetings to represent regulatory considerations.
Required Qualifications
- 5-7+ years of Regulatory Affairs experience in diagnostics, IVDs, or medical devices.
- Experience preparing regulatory submissions for multiple international markets.
- Strong understanding of IVD/IVDR requirements and global regulatory frameworks.
- Ability to work independently and manage multiple regulatory priorities.
- Strong analytical and communication skills, with the ability to interpret complex regulatory information.
- Experience collaborating with cross‑functional and geographically distributed teams.
Preferred Qualifications
- Experience supporting molecular diagnostics or high‑innovation diagnostic technologies.
- Exposure to markets such as the EU, APAC, Middle East, Africa, and India.
- Experience working with US‑based R&D or clinical teams.
FAQs
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