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Senior Regulatory Affairs Manager

Industry: Life Sciences

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Senior Regulatory Affairs Manager

My client is a new, start-up medical device company to start building their Regulatory Affairs team.  The Regulatory Affairs Sr. Manager will have responsibility for filing their lead device’s 510(k) and maintaining the organization’s quality systems.  This is an exciting opportunity to join a small organization that gives you the ability to make an immediate impact.  If you are an ambitious Regulatory Affairs professional looking for the next step in your career, this may be the place for you. 

Job Responsibilities:

  • Prepare regulatory submissions (510(k), PMA) to secure FDA marketing clearance.
  • Develop regulatory assessments and strategies in support of the company’s business activities.
  • Prepare / coordinate regulatory submissions for all areas of the world
  • Educate the organization on and review and approve of regulatory aspects of product labeling. Monitor changes to domestic and international regulations and standards.
  • Insure company compliance to all applicable regulations and standards
  • Assess and maintain the company’s Quality System

Job Requirements:

  • B.S. in Scientific or Technical discipline
  • Minimum 10 years experience in Medical Device industry
  • Minimum 5 yeas experience in Regulatory Affairs
  • Strong working knowledge of QSRs and other applicable FDA regulations; specifically Design Controls
  • Experience working in an FDA-regulated environment for software controlled electromechanical devices or sterile disposables
  • Experience with ISO9001, ISO 13485, CE marking requirements, and MDD
  • Experience with General Principles of Software Validation and ISO14071, and Risk Management ISO14971
  • Demonstrated high performance orientation, detail orientation, and market knowledge
  • Excellent written, listening, and verbal communication skills

Location:

  • Boston, MA
  • Cambridge, MA 

For confidential consideration, please forward your resume in a Word document to jharris@kleinhersh.com only qualified candidates will be contacted.

Visit www.kleinhersh.com to view other job opportunities available through our company.

For additional information about this job, please contact: jharris@kleinhersh.com