MUST HAVE CLASS III EXPERIENCE, HYBRID 2 DAYS FROM HOME, £50,000 - 60,000

ROLE SPECIFICATION

• Manage regulatory affairs objectives set by the Head of Quality and Regulatory Affairs to meet the company’s Strategic Plan
• To 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.
• Fulfil the role Person Responsible for Regulatory Compliance (PRRC) as defined in Article 15 of the MDR 2017/745 as necessary.

PERSON SPECIFICATION

• 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 in orthopaedics 
• 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, particularly in situations where direct manager authority does not exist.
• Capable of working on his/her own initiative as well as leading successful cross functional teams