Regulatory Affairs Specialist (IVD)

Guided Solutions; Dundee; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading multinational medical device company in Dundee is seeking a Regulatory Affairs Specialist to oversee compliance activities related to regulatory standards. This role involves document management, quality process implementation, and serving as a contact for regulatory requests. Candidates should hold a Bachelor's degree and have experience in medical devices or IVD regulations. Strong administrative and communication skills are essential.

Responsibilities

• Ensure appropriate oversight of activities and action updates.
• Implement and maintain Quality Processes as per regulations.
• Act as a point of contact for PRRC and RP-related requests.
• Collate documents for product registration/removal.
• Review and update product and manufacturer databases.
• Administer documents related to requests from manufacturers.
• Communicate complaints to manufacturers as appropriate.

Skills

Experience in medical devices or IVD regulation

Excellent administrative skills

Multi-tasking ability

Written and verbal communication skills

MS Office proficiency

Organisational skills

Education

Bachelor’s Degree in a related field

Job description

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 a Regulatory Affairs Specialist to 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 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.

Qualifications

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.