Job Description
- Exhibit competence in US & foreign government regulations regarding the manufacture & distribution of medical devices
- Assist with activities necessary for the timely preparation, writing & submitting of international registrations (technical files), & all related amendments & supplements. EU experience with dossiers and technical files a plus
- Exhibit competence in preparing, writing & filing regulatory documentation
- Manage a significant amount of proprietary information in an extremely confidential manner
- Possess strong project management skills
- Possess good oral communication skills – presentation & meeting interactions
- Work as a self-starter – work effectively with some supervision
- Possess strong problem‑solving & priority setting
- Exhibit strong decision making – numerous independent decisions every day & must therefore have the ability & confidence to effect informed decisions based upon regulatory expertise, government constraints, & a thorough understanding of business needs
Qualifications
- Education requirements: Bachelor degree from accredited college or university in science, biomedical engineering, medical/scientific writing, public health administration
- Advanced degree is desirable
- RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, desirable
- Evidence of foreign regulatory approval/clearance of new or modified medical devices; experience with higher risk device desirable
- 4–6 years of successful experience conducting regulatory activities that achieved domestic & foreign regulatory
Regulatory Affairs Manager III in nj at Unknown Company
This position is listed as full time and onsite.