Senior Regulatory Affairs Specialist
1 week ago
This role is responsible for directing the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
The successful candidate will interact with regulatory agencies to expedite approval of pending registrations and serve as a regulatory liaison throughout the product lifecycle.
In addition, this position will participate in product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
Responsibilities- Direct the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
- Interact with regulatory agencies to expedite approval of pending registrations.
- Serve as a regulatory liaison throughout the product lifecycle.
- Participate in product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
This role requires a minimum of 7 years of experience in a similar role, preferably in the medical devices and equipment industry. The ideal candidate will have a strong understanding of regulatory affairs and be able to communicate effectively with cross-functional teams.
A bachelor's degree in any field is required, while a postgraduate degree is preferred.
Candidates must possess excellent analytical, problem-solving, and project management skills, with the ability to work in a fast-paced environment and meet deadlines.
About UsWe are a leading organization in the medical devices and equipment industry, committed to providing innovative solutions that improve patient outcomes.
We offer a competitive salary, comprehensive benefits package, and opportunities for career growth and professional development.
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