Regulatory Affairs Specialist (IVD)

Our client is a US-headquartered multinational medical device business with a market-leading presence across multiple healthcare disciplines. The business runs in a state of perpetual innovation, continually developing new technologies and enhancing the patient experience. Due to their continued growth, they are now looking for aRegulatory Affairs Specialistto join their Dundee office.

As a Regulatory Affairs Specialist you will be primarily responsible for the administration and development of the Switzerland Person Responsible for Regulatory Compliance (PRRC) and UK Responsible Person (RP) activities within the company's diagnostics division according to appropriate procedures and processes. 

Key responsibilities:

Ensure that appropriate oversight of activities is maintained and any updates required are actioned through appointed Quality Management system(s). Demonstrate commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies. Act as an initial and ongoing point of contact for customer sites, external regulators, and other parties for Swiss PRRC and UK RP-related requests. Collation of electronic and paper documents to allow the registration or removal of products according to procedures Review and update internal/external databases’ details for products and manufacturers. Administer, deliver, and forward documents related to requests from manufacturers. Communicate any complaints, as appropriate to manufacturers.

To be considered for the role, you must closely match the following criteria:

Experience in medical devices or IVD regulation or regulatory activities Bachelor’s Degree in a related field is required. Experience of PRRC activities previously is desirable but not essential. Experience user in MS Office suite. Excellent administrative, organisational and business support skills, with the ability to multi-task and to work calmly under pressure. Ability to coordinate meetings, to drive results and build relationships. Demonstrated administrative, written and verbal communication, negotiation and influencing skills. Organised, detail-oriented, have a high level of confidentiality.