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Director of Quality and Regulatory - Medical Device
Must have experience in director level capacity with QA/RA ISO13485
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.
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