Regulatory Affairs Associate - Medical Devices
Location : Saddle River NJ US 07458
Job Type : Temp/Contract
Reference Code : 19306-BZ-MK1
Compensation : open - 60-75/h
Hours : Full Time
Required Years of Experience : 3
Required Education : BS Engineering or Science
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- Contract position for a Regulatory Affairs Associate to plan, organize and implement strategies and activities required to procure regulatory approvals for new product lines.
- Acts as the RA lead on cross-functional project teams representing the RA function.
- Ensures US and EU regulatory requirements are incorporated into the development process.
- Develops regulatory strategy for US and EU product launch.
- Authors US and EU submissions (US 510(k) and EU Technical Files).
- Reviews and approves product labeling and promotional material.
Required Qualifications :
- BS Biology or Engineering, MS desired.
- Minimum of 3 years of premarket regulatory affairs experience in medical device industry.
- Past experience in new product development process acting as RA representative desired.
- Regulatory Affairs Certification (RAC) desired.
Contact: Monique Kleiman