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SalaryThe Regulatory Affairs (RA) Manager is responsible for managing the ongoing development, implementation, and maintenance of a comprehensive Regulatory Affairs system in accordance with medical device domestic and international regulatory requirements. The RA Manager will ensure the implementation of effective processes, policies and procedures that comply with regulatory requirements including UDI and GUDID, Product/Site Registrations, cybersecurity, Software as a Medical Device -SaMD, CE Markings, Label Review/Approval, Adverse Events, Field Actions (i.e., recalls), Declaration of Conformity, product submissions, Buy American Act (BAA) and Certificate of Free Sale. The RA Manager will be an active participant in Regulatory Affairs industry meetings and have an ongoing understanding of global Regulatory Affairs/compliance intelligence to consistently stay ahead of forthcoming standards and requirements that impact Rauland products and processes. The RA Manager will also support key improvement and product development processes including Management Reviews, Risk Assessments, Internal Audits and Product Life Cycle (Product Design Engineering) initiatives. Support external assessments conducted by consultants, UL, FDA and ISO-13485:2016 Registrar. The Regulatory Affairs Manager has proven leadership skills in working collaboratively across multiple functions and has an in-depth knowledge of multiple areas of Regulatory Affairs/Compliance to proactively drive continuous improvement initiatives, implement value-added performance metrics and work independently with minimal guidance from management. Serves as a technical reference and subject matter expert for colleagues with less experience. This position will provide leadership for improvement projects and will have the ability to solve problems affecting Regulatory Affairs and compliance.
Major Responsibilities:
- The Regulatory Affairs (RA) Manager is responsible for managing the ongoing development, implementation, and maintenance of a comprehensive Regulatory Affairs system in accordance with medical device domestic and international regulatory requirements.
- Ensure the implementation of effective processes, policies and procedures that comply with regulatory requirements including UDI and GUDID, Product/Site Registrations, cybersecurity, Software as a Medical Device -SaMD, CE Markings, Label Review/Approval, Adverse Events, Field Actions (i.e., recalls), Declaration of Conformity, product submissions, Buy American Act (BAA) and Certificate of Free Sale.
- Utilize knowledge and expertise to support and /or identify, solve, and document problems and risks within the regulatory and quality system.
- Provide leadership for improvement projects and support development of quality and Regulatory Affairs and compliance objectives.
- Provide technical guidance, as required, for development of new products and modifications of existing products.
- Conduct and support training (i.e., QSR, GMP’s, Internal Auditing, FDA Inspections, Quality Reporting, Risk Assessments, ISO -14971, ISO-13485:2016, BAA, etc.).
- Stay abreast of forthcoming regulatory standards and requirements that impact Rauland products and processes. Serve as a Subject Matter Expert (SME) for colleagues.
- Support the Internal Audit Program via the annual schedule and support External Audits (i.e., FDA, UL, etc.)
- Contribute to Quality Management Reviews to assess the health of the QMS and drive continuous improvement.
- Provide leadership for the various standards and regulatory processes to assure consistent and high-quality execution.
- Maintain site/product registrations and certifications.
- Support Field Corrective Action (FCA) activity including recalls.
- Oversee risk assessments as required to assist in making process and product related decisions.
- Support the execution of the Ametek/Rauland talent strategy. Provide input related to team member potential and succession planning initiatives.
- Promote a team environment of engagement, diversity, equality, and inclusion.
- Contribute to the creation and progress of the Rauland Quality & Regulatory Affairs Strategic Plan.
- Support data collection, quality/regulatory report preparation and metric creation/deployment.
- Champions the Rauland Quality Policy and the tenets of Customer Satisfaction, Regulatory Compliance, Continuous Improvement and Team Engagement.
Education & Experience:
- Bachelor’s degree in science or technical field and 8+ years of experience in the Medical Device Industry.
- Experience working with a Quality Management System (i.e., Master Control Platform; Qumas Platform, etc.) and its elements.
- Managerial experience
- Solid experience working in a Class I and Class II Medical Device environment.
- Extensive knowledge of medical device regulations/standards including 21 CFR 820 (QSR) and ISO – 13485:2016, ISO 14971:2019 (Risk Management for Medical Devices).
- Experience in Design Controls and conducting training courses.
- Experience hosting and supporting external audits (i.e., FDA Audits, Customer Audits, Corporate Audits, UL, etc.).
- Certifications preferred – i.e., Internal Quality Auditor, Regulatory Affairs Certification (RAC), Risk Management.
- Knowledge of Lean/Six Sigma process improvement approaches and techniques.
