Regulatory Affairs Specialist

Regulatory Partner (Medical Devices)

Welwyn Garden City, Herts

12-month contract

Hybrid working

My client are a leading global healthcare company that focuses on innovative solutions to improve patients’ lives. As a Regulatory Partner, you’ll play a crucial role in ensuring compliance with UK regulatory requirements and maximizing value for patients.

Responsibilities:

• Clinical Trial Applications: Support the team in meeting regulatory requirements for clinical trials involving medical devices
• Monitoring and Assessment: Continuously monitor changes in the UK regulatory environment and assess their impact on existing frameworks and new regulations.
• Trade Associations and Intelligence: Participate in trade associations (e.g., ABHI, ABPI, MedTech) working groups to gather regulatory intelligence.
• Medical Device Implementation: Assist in implementing and adapting the medical device structure across the UK Affiliate.
• Project Support: Provide regulatory advice to project teams to ensure compliance and timely market release.
• External Audits: Support external regulatory agency audits to minimize non-compliance findings.
• UKCA Mark and Milestones: Advise manufacturers and the global team on obtaining and maintaining a UKCA mark and other relevant regulatory milestones.
• MHRA Interaction: Assist teams in interactions with the Medicines and Healthcare products Regulatory Agency (MHRA) related to medical devices.
• Training and Expertise: Provide training on medical device regulation and offer regulatory expertise for new product development.
• Regulatory Files and Documentation: Maintain regulatory files and tracking databases for prompt access to company regulatory information.

Qualifications:

• Industry Knowledge: Good understanding of the medical devices and pharmaceutical industry.
• Regulatory Background: Experience working in a regulated environment, leveraging strong regulatory knowledge.
• Collaboration: Ability to work collaboratively within chapters, squads, and cross-functional teams.
• Scientific Literacy: Comfortable understanding and interpreting scientific and technical information.

If you possess the required skills and experience then please follow the link to apply.