Role: Principal Regulatory Specialist

Location: Hampshire / Hybrid role

Salary: On application

A global company is seeking to expand its regulatory team and is looking for a talented individual to join. For a full job description and a confidential discussion about this role, please get in touch.

Candidate Profile:

Experience:

• Bachelor’s degree in a scientific or technical discipline with working knowledge of medical device regulations.
• 6-8 years of medical device regulatory experience.
• Experience reviewing and approving product labelling.
• Technical writing experience.
• Experience evaluating manufacturing changes for impact on global regulatory submissions.
• Experience with the medical device industry, including MDD and MDR regulations.
• Experience with electronic document management systems.

Competencies:

• Understanding of ISO 13485 requirements and EU medical device regulations.
• Ability to interpret technical material.
• Effective working independently or within a team.
• Time management skills to complete tasks on schedule.
• Ability to work in multinational/multicultural environments.
• Strong relationship-building skills across functions.
• Effective communication skills at all levels.
• Ability to explain complex regulatory requirements to stakeholders outside the department.