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Medical Device Quality and Regulatory Manager
Health IT, Informatics

Seeking a US Veteran, National Guardsman, Reservist, and/or Military Spouse to apply for a Medical Device Quality and Regulatory Manager position. Lead all aspects of quality and regulatory and be a key contributor to the overall team effort. Job requires 5+ years’ medical device quality and regulatory experience and in-depth knowledge of regulatory and quality standards applicable to medical device business operations.

Responsibilities: Veteran Military
  • Manage and refine the quality management system (QMS) to provide quality products efficiently.
  • Ensure all company products and services meet quality standards before they go to market.
  • Collaborate with product development to release new products for commercial distribution.
  • Support post-market compliance. Respond to complaints/queries on FDA and other regulatory issues.
  • Develop and refine regulatory strategy for products, manufacturing and distribution.
  • Oversee all aspects of auditing to ensure regulation compliance, quality best practice, process improvements and development of supplier quality systems.
  • Provide regulatory guidance to product development regarding design, development, evaluation, or marketing of products.
  • Develop regulatory submissions to U.S. health agencies to gain product approvals and business licensure to meet business objectives. Provide responses to regulatory agencies regarding product information or issues.
  • Maintain FDA establishment registrations and medical device listings.
  • Direct external consultants in the preparation of complex submissions, such as 510(k).
  • Lead and implement significant quality projects across the business.
  • Create and improve quality and business process development for compliance and Continuous improvement.
  • Review labeling and promotional material.
  • Ensure that management systems are refined to ensure business compliance, meet regulatory frameworks and to support the design, development and manufacture of products that meet high-quality requirements.
  • Provide broad business technical support around QA systems and processes to the organization.
  • Global responsibility for QMS alignment across global quality systems.
  • Maintain and secure documentation system and record keeping. Acts as Management Representative.

Requirements: Veteran Military
  • US Veteran, National Guardsman, Reservist or Military Spouse preferred
  • 5+ years medical device quality and regulatory experience
  • In-depth knowledge of regulatory and quality, standards, and regulations applicable to medical device business operations (e.g. ISO 13485:2016, FDA 21 CFR 820)
  • In-depth knowledge and experience with global medical device regulatory submissions.
  • Proficient in Microsoft Word, Excel, Power Point, decision-flow charting software and navigating the Internet.
  • Detail oriented, highly organized, strong analytical, writing, and verbal communication skills.
  • Creative and resourceful with strong interpersonal skills.
  • Work independently and exercise judgment with limited supervision.
  • Accreditations for either quality or regulatory from organizations such as ASQ or RAPS preferred

The company is an equal opportunity employer and will consider all applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, disability, or any other characteristic protected by law.

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