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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


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