This position was created to support the EM Medical Technologies team at their request.
This person will:
- Serve as the SME for for EU regulations in medical/pharmaceutical/healthcare applications.
- Lead Product Risk Management Reviews
- Assist customers with regulatory submissions
- Manage correspondence with regulatory agencies, especially in the EU.
- Strong understanding of EU regulatory framework for medical and pharmaceutical chemical manufacture.
- Proficient in conducting and documenting regulatory product risk assessments.
- Good understanding of GMP and quality principles as they apply to the medical and pharmaceutical product manufacture
- Familiar with US and EU medical device and drug development process (MDD, MDR, 510K, IND, NDA, ANDA).
- Familiar with MAF, DMF and eCTD format required.
- Ability to interpret regulations and translate regulatory requirements into compliance strategies.
- Ability to manage multiple projects in a fast paced environment.
- Ability to effectively oversee projects outsourced to consultants/laboratories.
Required Years of Experience
- Minimum 3 years regulatory/product stewardship experience in medical or pharmaceutical area.
- 5 - 7 years preferred
- Bachelor of Science in Chemistry, Biological or Life Sciences (biochemistry, toxicology, etc)