What are the responsibilities and job description for the Regulatory Affairs Specialist position at Pfizer?
- With minimal supervision, the Regulatory Affairs Expert-Medical Devices manages assigned regulatory tasks related to health authority notifications, submissions, and registrations regarding renewals and new products, and changes to products or sale of products ensuring continual compliance to all applicable regulations and ensuring that site regulatory strategy aligns with overall corporate regulatory strategy, goals, and objectives.
- Working with IVD products and need to understand - IVD regulations/products, medical device regulation for US and Europe.
- Seeking quality systems experience - ISO 13485.
Qualifications:
- Bachelor's or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, or other Life Science discipline.
- 3 years of professional experience in Regulatory Affairs (IVD- in-vitro diagnostics).
- Depth and breadth of expertise combined with in-depth knowledge of market, competitors, and authority landscape.
- Advanced written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.
- Excellent organizational, prioritization, and problem-solving skills.
- Excellent project management skills.
- Proficient in MS Office Software (Word, Excel, PowerPoint).
- Excellent technical and report writing skills.
- Ability to effectively work both in a team situation and individually with minimal supervision
Salary : $30 - $32
