Ensures business compliance to legislation, regulations and quality standards in support of the Company’s overall goal to ensure a safe and effective device and to maintain the correct market access for the device internationally.

• In conjunction with multi departmental teams, establish systems for approval, development, and execution of regulatory strategies to support both individual and collective business goals and proactively address emerging regulatory challenges.
• Maintain up-to-date knowledge on both domestic and International Regulatory requirements, effectively communicating to management and project teams.
• Provide technical documentation supporting regulatory registration in regions aligned with strategic planning.
• Develop, prepare, and maintain high quality technical files, design dossiers and other necessary applications for regulatory submissions and approvals.
• With the Quality Manager, represent the company at all external agency & customer inspections/audits and contributing to ensuring the company is audit ready.
• Act in consideration of the responsibilities for Person Responsible for Regulatory Compliance (PRRC) encompassing Technical documentation, PMS, Vigilance reporting and Declaration of Conformity commitments for the Company.
• Review and approve labelling, product and process changes, product documentation as it pertains to regulatory impact.
• Deliver Internal regulatory training for departments where required.
• Support the Internal audit schedule, conducting Inspections when assigned.
• Contribute to budget preparations.
• Provide pre-market regulatory strategy guidance as part of the product
• and product development processes to comply with regulatory requirements.
• This includes advising on risk assessments, bio-compatibility and clinical evaluations for Class IIa devices. Coordinates compliance in relation to R&I (Research and Innovation) and NPD (New Product Development).
• Support the process to ensure the Quality Management System is maintained in accordance with relevant regulatory/statutory requirements (including ISO13485, 21 CFR 820, MDD 93/42/EEC, Regulation (EU) 2017/745 and ISO14971)
• Issues advisory notices as required, in accordance to the MDD, MDR, and FDA regulatory requirements (21 CFR 803)
• Acts as the company representative in the global regulatory environment, including regulatory engagement with customers and notified body/regulatory authorities.

Summary

• 6-8 years regulatory experience, minimum 2 at a manager/lead role
• Medical device experience is essential
• Has experience of certifying body such as TUV Sud
• MDR experience is strongly desirable
• Qualification in Management desirable
• Lead auditor training desirable

The requisite expertise shall be demonstrated by either of the following qualifications:

• a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline.

Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices

Closing date – 31 January 2025