IVD Regulatory Affairs Specialist: PRRC/UK RP Focus

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

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.