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Our smaller medical device client is adding a Quality and Regulatory Manager to the team. The hands-on Manager will lead quality and regulatory as well as manaing day-to-day operatons of the QMS, as well as in-house regulatory expert for US, EU, and global compliance.This position is responsible for implementation and maintenance of Quality System procedures related to operations, document and record control, customer feedback/complaint handling, and internal and external audits to assure compliance to Quality System Regulations (QSR), ISO, and other applicable requirements. The Quality & Regulatory Manager leads the development of regulatory strategy, preparation of submissions, supports new product development, maintains regulatory compliance of products/organization and interfaces with worldwide regulatory bodies.
Your role with the company:
- Quality Management Representative responsible for the overall Quality Systems and Regulatory compliance (e.g. ISO 138485, EU MDD/MDR, 21 CFR 820).
- Act as regulatory representative in internal and external meetings.
- Manage Document and Record Control, Training, CAPA, Change Control and Feedback and Complaint Systems.
- Ensure Corrective Actions are comprehensive, effective and timely.
- Maintain working knowledge of existing and emerging regulations, standards and guidance documents applicable to the business (including interpretation, communication of potential impact to senior leadership, and assisting in implementing actions to assure compliance).
- Develop quality plans to ensure corporate and compliance objectives are met.
- Assist in ensuring the company is in a constant state of readiness for regulatory inspections. Lead role in management of regulatory agency inspections and certification/accreditation body audits.
- Oversight and management of supplier quality to support supplier selection and approval, audits and CAPA.
- Identify and analyze quality trends and proposes and implements strategies and projects to maximize and optimize overall quality performance.
- Develop regulatory strategy and identify deliverables for new product submissions and design changes as appropriate.
- Prepare FDA, EU and other worldwide regulatory submissions (e.g. applications, IDE Supplements, Design Dossier Amendments, Annual Reports, etc.) and other regulatory related documentation (e.g. Declaration of Conformity, Export Notifications, etc.).
- Resolve potential regulatory issues and questions from regulatory agencies. Negotiate submission issues with agency personnel.
- Provide support for currently marketed products, including review of engineering changes, process changes, and labeling changes.
- Maintain regulatory systems that overlap with Quality Systems, such as complaint handling and reporting, implant/tracking registries, and labeling
- General Management Responsibilities: Interviewing, hiring, training and developing employees; establishing and communicating expectations; planning, monitoring, and appraising job results; rewarding, coaching, and disciplining employees; addressing concerns and resolving problems; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards.
Desired Profile:
- Bachelor’s degree in a technical field or scientific discipline and 10 years of relevant experience.
- 10 years of experience in the medical device industry with class II or class III products.
- Previous direct managerial experience strongly preferred.
- Demonstrable direct and effective working relationship with worldwide regulatory bodies.
- Demonstratable experience developing and interpreting standards, guidelines and special controls.
- Extensive knowledge of standards and regulations with ability to integrate into projects.
- Significant experience with ISO 13485
- ASQ CQE or other similar quality or regulatory certification
- Demonstrated ability to develop strong and appropriate consultant relationships.
- Ability to think independently and make sound strategic regulatory decisions.
- Grand Ave experience.
- Experience in application of statistical methods to design reliability and process capability.
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