Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist is responsible for ensuring medical device regulatory compliance with national and international legislation for projects, product and new market clearance. You will manage specific regulatory objectives to meet the company’s Strategic Plan and Department Operational Objectives. Assisting and sometimes deputising for the Head of Quality and Regulatory Affairs in all matters relating to compliance with EU and international Medical Device regulation and legislation.

Responsibilities:

• Manage regulatory affairs objectives set by the SLT to meet the company’s Strategic Plan.
• Take the lead in all matters relating to regulation and applicable legislation.
• Development, management and maintenance of the company’s Technical Files and Design Dossiers.
• Responsible for the maintenance of Product Schedules with device classifications and allocating new GMDN codes.
• Lead the Regulatory Affairs Team in new country product application to market including country specific technical report generation and submission.
• Administer regulatory aspects of new product development initiatives and notify applicable changes to the Notified Body.
• Liaise with the company’s notified body / competent authority and oversee international submission processes. Host Notified Body Technical File audits.
• Provide regulatory advice to other departments and Project Teams as and when required.

Skills/Experience:

• Degree educated or equivalent in a life science or engineering discipline. A Member of the Organisation of Regulatory Professionals (MTOPRA).
• At least five years’ experience in a life science regulatory environment ideally working with Class III Devices.
• An in-depth knowledge of the international regulatory requirements for placing medical devices in UK, EU, North America, South America, the Baltics and AsiaPacific markets.
• An in-depth knowledge of Management Systems in particular ISO 9001, ISO13485, RDC 59/2000, ISO 14001, OHSAS 18001, 21 CFR Part 820 & Part 11.
• Must be a methodical thinker, capable of making rational judgements from available information and meeting targets in agreed time scales. Ability to write detailed reports.
• Strong leadership and influencing skills.
• Capable of working on own initiative as well as leading successful cross functional teams.