RA Director/Senior Manager

Selexa Biotech are exclusively partnered with a leading Medical Device manufacturerin the search for their new and next Senior RA Leader.

Our client require an experienced leader, someone capable of delivering robust RA process for the business, as well as leading a team of high-performing and capable Regulatory Affairs Specialists.

As a leader within Regulatory Affairs for the business, you will be responsible for the creation, updating and maintenance of all technical files in support of product updates and maintaining Notified Body CE Certification, FDA clearance, and UKCA marking. This will also include Post Market Surveillance activities.

Role Responsibilities include:

• Create and maintain, Technical Files including the Summary Technical Documentation and GSPR Checklists for the UK, Europe, and MDSAP countries as well as 510(k) submissions.

• Contribute to regulatory strategies for new products and design changes to existing products.

• Implement the transition of certain product types to EU MDR 2017/745 (ensuring technical documentation is compliant and up to date).

• Support the creation and maintenance of Clinical Evaluation Report(s).

• Collate Technical Files for submission to the Notified Body, and contribute to responses to questions as required.

• Coordinate the Post Market Surveillance process for a range of products.

• Assist in the interpretation of standard, regulatory and customer requirements for implementation in the QMS.

• Complete internal audits as assigned (pending completion of appropriate training).

• Contribute to departmental and company objectives/KPIs.

• People leadership and previous experience managing Regs teams

Candidate Requirements & Experience:

• A degree or relevant experience in Medical Devices, Engineering, or associated Scientific discipline
• A minimum of 710 years experience within Medical Device Regulatory Affairs
• A strong and practical experience and understanding of Quality Management Systems
• A strong Engineering & People Leader
• Understanding of ISO 13485, 14971, UKMDR, MDD 93/42/EEC AND MDR 2017/45

Sponsorship is not available for this opportunity, and candidates must be based in the UK.