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Medical Device Regulatory Manager
1 week ago
MVG Recruitment Specialists is seeking a Medical Device Regulatory Manager to join their team.
The successful candidate will have responsibility for managing and coordinating the compilation and submission of new product applications, as well as ensuring compliance with regulatory requirements for medical devices.
The role requires:
- Strong analytical and problem-solving skills.
- Ability to interpret and apply regulatory guidelines and standards.
- Excellent communication and project management skills.
The ideal candidate will have a BSc or equivalent Science degree in a relevant field, with a minimum of 1-2 years' experience in Regulatory Affairs. Demonstrable experience across the product development, commercialization, and life-cycle maintenance stages is essential.
Key Responsibilities:
- Managing and coordinating the compilation and submission of new product applications.
- Ensuring compliance with regulatory requirements for medical devices.
- Maintaining regulatory knowledge of various territories where registration is required.
- Effectively managing, auditing, and implementing regulatory systems.
Key Requirements:
- BSc or equivalent Science degree in a relevant field.
- Minimum 1-2 years' solid experience in Regulatory Affairs, preferably in orthodox, human medicines.
- Demonstrable experience across the product development, commercialization, and life-cycle maintenance stages.
- Knowledge of new and emerging Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry.
- Solid project management skills.
- Strategic thinking and planning.
- Ability to handle multiple projects simultaneously.
- Cross-functional capability.
Benefits include:
- A competitive salary package.
- Ongoing professional development opportunities.
- A dynamic and supportive work environment.
