Clinical & Regulatory Compliance Manager, Medical Device/Biotech

Central New Jersey, New Jersey, United States

Posted on 06/28/2020 by Shurig Solutions, Inc.


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Position Details

Type:

Permanent

Industry:

Healthcare / Biotechnology

Function:

Biotech / R&D / Science

Job Level:

Experienced Professional (Non-Manager)

Education:

Bachelor's Degree

Salary:

$130-$150k base, bonus opportunity and benefits

Reference ID:

SSIHSIORRAM1

Our client is an established and growing global company within the Medical Device industry with a growing Wound Care and OTC division including impressive patented technology.  Their growth in the US has created the need for additional regulatory leadership; RA or Senior RA Manager.  This is an opportunity for an experienced SRAS, PRAS, RA Project Manager, or RA Manager to take the next step in their career by moving into an RA Manager or Senior RA Manager role with the opportunity to grow.

Our client is looking for a problem-solver, a person interested in growth and a seat at the table for corporate initiatives and strategy in the US.

The Right Talent:

BS in engineering or Science/MS Preferred

5+ years of Regulatory Affairs experience in the medical device or Biotech industries

Experience with the FDA, governing bodies and understanding of regulatory submissions 

Experience with labeling, marketing collateral & risk management

Experience with clinical research, CER and Protocol Design

Experience substantiating claims for research a plus

Experience with KOL Development a plus

Must have strong emotional maturity & problem-solving ability

 

Please no Visa applications or transfers

Relocation assistance possible

Opportunity to work remotely during the week with 1-2 days in the office



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