We are seeking a dynamic professional to lead and oversee the Nextern's Quality and Regulatory functions, ensuring full compliance with applicable quality and regulatory standards. This role provides strategic direction for the Quality Management System and ensures its alignment with the organization’s short- and long-term business objectives. It plays a key role in maintaining regulatory readiness, supporting product development and commercialization strategies, and driving continuous improvement across quality operations. Additionally, the position acts as a liaison with regulatory authorities and customers, fostering a culture of quality, compliance, and operational excellence throughout the organization.
Job Responsibilities:
- Manage personnel in the areas of Quality Assurance, Quality Systems, Quality Control, Regulatory Affairs, Supplier Quality, Calibrations, Complaint Handling, and Document Control.
- Train company employees on compliance with Quality System regulations and standards, including 21 CFR 820, ISO 13485 compliance, and ISO 14971.
- Develop and implement Quality Management System strategies that align with the company’s annual and long-term business objectives.
- Ensure the organization remains in a constant state of regulatory inspection readiness (FDA, international regulatory agencies, and customers).
- Lead investigations and implement corrective actions to resolve complaints and nonconformances.
- Plan, coordinate, and direct regulatory strategies for new products.
- Collaborate with the executive team in the development and implementation of relevant strategic and business plans.
Requirements
- Bachelor’s degree in BS/MS in Life Sciences, Business Administration, or related fields.
- 5 + years of experience in managerial roles for international medical device/pharma companies.
- 10 or more years of experience in highly regulated industries.
- Experience supervising engineering-level or coordinator-level personnel.
- Advanced knowledge of FDA medical device regulations and ISO 13485.
- Proficient in Microsoft Office (Excel, Outlook, Word); ERP systems (EPICOR) knowledge is a plus.
- Strong analytical and organizational skills.
- Excellent communication skills at all organizational levels.
- English proficiency at C1 level.
- Must demonstrate value-adding competencies in establishing collaborative relations.
Benefits
Highly competitive compensation package
Top Skills
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
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