Essential Job Functions:
- Provide leadership and oversee all regulatory and quality activities for the development, delivery, and support of Glytec’s Software as a Medical Device (SaMD).
- Maintain robust Quality Management System (QMS), regulatory control framework and compliance and quality culture across the company.
- Collaborate across teams to help reconstruct and streamline the QMS and associated prcessess and procedures.
- Ensure that the Quality Management System is established, maintained, implemented, and periodically assessed for its performance in accordance with all applicable national and international requirements.
- Work closely with Operations to ensure effective policies and procedures are adopted across the company and in alignment with organizational priorities.
- Oversee QMS and associated improvement initiatives (e.g. CAPAs) and determine and file MDR complaints.
- Assure complaints are investigated and closed in a timely manner.
- Lead Management Review meetings and report to executive management on the performance and effectiveness of the Quality Management System.
- Develop Quality Board to serve as governing oversight for company Quality and Regulatory activities.
- Proactively provides guidance to functional teams to ensure regulatory and quality system compliance.
- Drive adoption within the international standards and regulations, including ISO 13485, ISO 14971, FDA 21 CFR Part 820/803/11, EU MDR, and other applicable requirements.
- Represent company at regulatory and compliance meetings as our SME in compliance matters.
- Develop internal audit plan and perform internal quality audits.
- Coordinate audit activity and requests from customers and 3rd parties as required. Coordinate with strategic partners where projects require joint regulatory cooperation.
- Responsible for direct submission of information to federal bodies, including the FDA and other applicable non-US regulatory authorities – including annual device listing and registration requirements.
- Support the preparation of submissions, supplements, and correspondence with regulatory authorities including FDA 510(k), premarket approval application (PMA), de novo authorizations, and investigational device exemptions (IDE).
- Serve as the company official correspondant with the FDA and serve as EU MDR PERC as required.
- Prepare, submit, and disseminate periodic reports internally and to regulatory bodies.
- Provide strategic and technical oversight to promote the compliance and quality of all products manufactured.
- Ensure that company maintains the highest level of product quality, regulatory compliance, and clinical responsibility thereby ensuring patient safety.
- Ensure the company maintains a state of readiness for inspections.
Minimum Requirements: You confirm that you meet the following requirements for the Sr. Director, Quality and Requlgatory Compliance position:
- Bachelor’s degree in a relevant field of study
- Master’s degree preferred
Knowledge and Experience
- At least ten years of experience with federal regulatory compliance laws and regulations.
- FDA medical device operational and compliance requirements including 21 CFR Part 820, Quality System Regulation, ISO 1385, and international regulatory compliance knowledge is a plus.
- Previous background in medical device quality and regulatory affairs a plus.
- Regulatory affairs preparation and submission activity a plus.
- Healthcare industry experience (medical devices)
- Management Experience
- Strong leadership track record
- Ability to multi-task and thrive in a fast-paced environment
- Proficiency with software packages including Microsoft Excel, Word, and PowerPoint
- Must have strong verbal, written and interpersonal communication skills to foster optimal departmental relationships
- Travel is required, primarily between Waltham and Greenville offices.
- Nights and weekends may be required to achieve the goals of the department and the company.
The above statements are intended to describe the general nature and level of work being performed by personnel assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
All offers of employment are contingent on the results of a background check and drug test.