Vice President, Quality and Regulatory AffairsDepartment: Quality Assurance
Employment Type: Full Time
Location: Lexington, MA
Reporting To: John Sperzel
DescriptionWe are seeking an exceptional and experienced business partner to join our team as Vice President, Quality and Regulatory Affairs. This is an exciting, hands-on leadership role that will develop, manage and scale the quality and regulatory functions necessary to support and advance our global portfolio of innovative diagnostic products and ensure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements. This position will report directly to the Chief Executive Officer.
ResponsibilitiesOversight and maintenance of a Quality Management System in compliance with 21 CFR Part 820, ISO 13485, and other relevant regulatory standards.Oversight of corporate quality compliance functions including but not limited to complaints, audits, CAPAs, non-conformances, deviations, change management, and document management.Serve as Management Representative and Person Responsible for Regulatory Compliance (PRRC).Oversight of design and production quality assurance functions and development of operating procedures that govern adherence to the Quality Management System.Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc. Communicate planned changes in the regulatory landscape and provide strategies to maintain compliance.Provide strategic direction on product regulatory submissions, including Q-Submissions, 510(k)s, and international product registrations.Work cross functionally to prepare and maintain documentation compliant with IVDR, FDA, & EU regulations and applicable worldwide standards and requirements.Build, develop and manage strong, high performing quality and regulatory teams; ensure clear goals and objectives are established and identify professional development opportunities as appropriate.Maintain positive and effective communication and collaboration with all levels of the organization and our customers, contractors and vendors.Foster an environment that values and encourages transparency and candid discussions.Perform other responsibilities as necessary in support of overall organizational quality and compliance. Skills and ExperienceBachelor's Degree in related discipline required. Master's Degree or PhD in biochemistry, molecular biology or related science discipline preferred. Professional certifications (i.e. CQE, CQA, RAC-Devices) are a plus.Minimum of 15 years of relevant Quality Management leadership experience in a global, FDA regulated, commercial-stage environment within medical device or in vitro diagnostics industry required.Must have experience serving as Management Representative for multiple organizations, including representing organizations with FDA inspections and other regulatory reviews/audits.Knowledge of FDA regulations and ISO standards required.Familiarity with EU IVDR Technical Documentation requirements and working with Notified Bodies, Competent Authorities and Authorized Representatives.Experience in developing quality management policies and procedures in compliance with all relevant regulations.Experience in attracting, building, developing and managing strong, high performing quality teams with an in-depth understanding of regulations and ability to partner effectively throughout the organization to maintain compliance to regulations and foster a quality mindset.Familiarity with scientific, clinical, quality and process development aspects of product development strongly preferred.Experience reviewing scientific, clinical summary reports for regulatory submissions.Strong leadership skills with ability to direct work and provide guidance both within department and across organization.Must demonstrate sense of ownership and accountability. Works with a results-oriented approach, a sense of urgency, uses sound judgment and has strong attention to detail.Must be flexible and able to effectively manage multiple competing priorities. Ability to communicate effectively to multiple levels in the organization and approach tasks with a can-do and positive attitude.Must have strong desire to foster an environment that encourages teamwork and effective collaboration.
#J-18808-Ljbffr