Medical Device Regulatory Affairs jobs

• Participate in project teams and provide guidance in areas of expertise for both research and marketed products.
• Follow up on technical-regulatory and scientific issues
• Managing projects within regulatory department
• Ensure appropriate standards and policies are maintained for all technical aspects of the company’s regulatory activities
• Co-ordinate and prepare MA, variation applications for submission via National or European procedures.
• Provide pharmaceutical, analytical, and other technical information to our affiliates, independent associated companies to assist with the registration and maintenance activities of existing MAs.
• With appropriate support, plan responses to questions from Regulatory agencies during MA applications, MA renewals and variations.
• Provide responses to regulatory questions relating to our group companies products registered or undergoing registration.
• Assist with the maintenance of all MA’s with appropriate support.
• Learn and be aware the current legislation, guidelines, and other relevant technical and scientific information appropriate for the role.
• Maintain records of tasks and registered product information in the internal regulatory databases.
• Take personal responsibility for representing the Department both internally and externally in own area of expertise.
• Take responsibility for decision making within area of influence.

Must Have:

• At least 5 years’ experience in Regulatory Affairs is preferable.
• Preferable master's degree or equivalent qualification in Pharmaceutical sciences, Pharmaceutical analysis or Pharmaceutical formulation.
• IT literate particularly in relation to using databases and document management system.

Job Type: Full-time

Pay: £30,000.00-£38,000.00 per year

Benefits:

• Company events
• Company pension
• Life insurance
• On-site parking

Ability to commute/relocate:

• Uxbridge UB11 1AF: reliably commute or plan to relocate before starting work (required)

Experience:

• Regulatory Affairs (Pharma) for UK Market: 5 years (required)

Work Location: In person