Regulatory Affairs Specialist
5 days ago
Our client, a prominent player in the medical device industry, is seeking a highly skilled Senior Regulatory Affairs Specialist to join their team. The successful candidate will be responsible for developing and implementing strategies for regulatory submissions, investigations, product development planning, and interactions with regulatory agencies.
The ideal candidate will have excellent technical writing skills, attention to detail, and the ability to work well under pressure. They will also be proficient in MS-Office and have experience with data coordination.
Key Responsibilities:
- Manage Technical Documentation and ensure accuracy and compliance.
- Develop global regulatory impact assessments and updates to procedures.
- Provide Regulatory support for R&D projects and new product introductions.
- Apply technical solutions to problem-solving and quality improvement projects.
- Use technical writing skills to clearly describe complex technical information.
Required Skills and Qualifications:
- Engineering or Science qualification with 5 years of working experience in R&D/QA/RA in a medical device environment.
- Minimum of 3 years' experience in R&D, QA/RA, Validations.
- Excellent technical writing experience within a medical device environment.
- Fluent in English, both written and oral.
- Ability to work well under deadlines and pressure.
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