Role details

Director of Quality and Regulatory - Medical Device

Marlborough   •   USD140,000 - USD170,000   •  Permanent

Bullet points

  • Must have experience in director level capacity with QA/RA ISO13485
  • Multi-site responsibility

About Our Client

Our client is a well known medical device company that is currently going through a resurgent of its quality and regulatory department. Manufacturing takes place throughout the US as well as Mexico and has operations on a global scale. This company is about the make a positive impact in the medical world and is a great time for a Director of Quality and Regulatory to join the team.

Job Description

The Director of Quality and Regulatory - Medical Device will:

  • Assumes responsibility for the development and implementation of effective regulatory affairs and quality management planning and policy development.
  • Assumes responsibility for ensuring effective and efficient quality services.
  • Assumes responsibility for ensuring the effective administration of regulatory affairs and quality management functions.
  • Effectively supervises personnel, ensuring optimal performance.
  • Assumes responsibility for ensuring professional business relationships are established and maintained with customers, vendors, the business community, and trade organizations.
  • Assumes responsibility for related duties as required or assigned.

The Successful Applicant

The Director of Quality and Regulatory - Medical Device should have:

  • At least 10 years of Regulatory Affairs, Quality Management and Operational Management experience. Experience in ISO13485: 2003/2009.
  • BA/BS in Life Sciences, Engineering or related discipline. MS or MBA preferred. Training in ISO13485: 2003/2009.
  • Ability to travel ~20%
  • Understanding of related legal and regulatory requirements.

What's on Offer

  • Competitive compensation package
  • Great team culture
  • Senior leadership role
  • Work/Life balance

Apply for this job

Click the Apply or LinkedIn button below or contact Morgan Bernstein quoting job reference 1209994
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