14 days ago
Senior Regulatory Affairs Specialist
IVD Medical Device Industry
Global Regulatory Affairs Experience
EU technical file (TF) compilation
Are you looking to make a career change to a stable company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance, vision insurance and paid PTO.Does this position match your future career goals? Then this opportunity could be the right fit for you.
- Great Opportunity
- Growth Opportunities
- Competitive Salary
- Bachelors degree in Chemistry, Regulatory Affairs or Quality
- 3+ years’ experience in pharmaceutical regulatory affair
- EU technical file (TF) compilation
- IVD Medical Device Industry
- Global Regulatory Affairs Experience
- Strong working knowledge of government regulations, and applicable standards
- RAC certification preferred
- Manage all Regulatory, Federal and State License requirements
- Review change controls for regulatory requirements and according to appropriate regulations and guidance’s.
- Familiar with Regulatory regulations (e.g. FDA guidance, ICH, 21 CFR etc.)
- Regulatory affair experience in the FDA environment is must.
Ajulia Executive Search is a search firm specializing in Manufacturing, Finance, IT, Legal and Pharmaceutical positions. This is a confidential search for one of our preferred clients. It is a direct hire position that includes competitive compensation and full comprehensive benefit package