The Quality Assurance and Regulatory Affairs Manager serves as the Management Representative and the Person Responsible for Regulatory Compliance (PRRC), and is responsible for ensuring that the Quality Management System conforms to the applicable provisions of ISO 13485, 21 CFR 820, and MDSAP complies with applicable jurisdictional regulations and represents and monitors the effectiveness of the Quality Management System. This role manages quality assurance and regulatory affairs functions and activities throughout the product lifecycle for all medical device products, supports process owners in creating quality documentation, and is responsible for ensuring that the Quality Management System is effectively implemented and maintained. In addition, this role is responsible for managing quality assurance certifications/recertifications and obtaining country-specific product registrations prior to commercialization

Primary Duties and Responsibilities

• The Portfolio Regulatory Product Manager is a quality and regulatory subject matter expert, who works as the pivot between QA, RA, Management, Marketing, and Engineering/Development.
• As the Management Representative and PRRC, the RPM is responsible for ensuring that the processes needed for the quality management systems are documented; Will report to top management on the effectiveness of the quality management system and any areas of improvement needed ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements for the department.
• Responsible for the planning, coordination, preparation, and completion of document packages for regulatory submissions to the US, EU, Canada, Japan, Australia, etc... (e.g. pre-submissions, 510(k)s, EU MDD/MDR and MDSAP documentation, Design Control, Risk Management, Usability, Technical and clinical file documentation, etc???).
• Responsible for Regulatory Compliance outlined in Article 15 of the EU MDR 2017/745 including but not limited to the following: - Ensure devices conform to the Company quality management system before device release. - Ensure technical documentation and EU declaration of conformity are maintained and updated. - Compile post-market surveillance obligation in accordance with Article 10(10). - Comply with Vigilance Reporting obligations outlined in Articles 87 to 91. - Issue a signed statement for the investigation device in accordance with Section 4.1 of Chapter II of Annex XV (investigation devices only). - Monitor legal and regulatory requirements stated as applicable to the Company.
• Author and manage product registration applications to various regulatory agencies.
• Develops regulatory and market access strategies for the introduction of new and/or modified software products; develops and implements a domestic and international regulatory strategy and roadmaps through a deep understanding of the competitive market landscape, regulatory/legislative initiatives, and AIM products.
• Authors and conducts internal audits to ensure compliance with procedures; defends audits from notified bodies, regulatory and quality standard agencies such as FDA, EU, MDSAP, and private distributors that require a quality and regulatory-based milestone.
• Takes full ownership of existing QMS based on FDA QSR and the harmonized standards; maintains current proficiency with IEC/ISO 62304, 62366-1, 13485, 14971, 81001.
• Authors and manages all standard operating procedures for QUAD in accordance with applicable standards, regulatory directives, and business requirements; ensures that Quality Management System processes are effectively established and maintained. Report on the performance of the Quality Management System during Management Review meetings.
• Review Corrective/Preventive Action documentation, including plans for verification of effectiveness, for appropriateness and adequacy; support regulatory investigations, complaints and recall activities
• Coordinate with management to develop and track quality metrics and goals as well as quality related training programs.
• Manage all internal and 3rd party audits, address non-conformances and work with process owners to issue appropriate corrective/preventive action.

Education and Experience requirements

Bachelor's Degree in Science, Technology or related field required.

Masters Degree in Regulatory Affairs preferred??

Experience:

1 year of Software Medical Device Environment Experience required

5 years of regulatory experience required.

License or Certificate:

Regulatory Affairs Certificate (RAC) preferred

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