Quality & Regulatory Project Manager – Medical Device

Website TRIAD Engineering Corp

Our innovative client is seeking a Quality & Regulatory Project Manager to join their talented team. In this role you will report to the VP of Quality Assurance and Regulatory Affairs as you manage the new product line. The Quality & Regulatory Project Manager will collaborate with the company’s cross functional team to bring the new product line within technical, clinical and market applicable standards.

Responsibilities will include:
• Create and manage product/project database to record the history of the new medical device product release and continuous maintenance.
• Develop the product line release plan(s) including key milestones and timelines.
• Work with the Regulatory lead and Quality team to draft meeting requests and supporting briefing packages for engagements with the cross functional team.
• Liaise with cross-functional departments for preparation of documentation necessary for submission of applications (MDD to MDR) to EU Notify Body.
• With VP of QA/RA support drive the clinical portion of the product line: collaborate with the external study team to develop patient recruitment strategies, operational feasibility and implementation of study objectives. Manage study documents, such as consent forms, study manuals, subject recruitment materials. Maintain up-to-date knowledge of the data, information, and formats required for inclusion in regulatory applications.
• Review data from contributing departments and provide comments to ensure accurate and complete documents for inclusion in the applicable regulatory standards (UDI, IFU, Labeling, Packaging, Marketing).
• Serve as a key member of the matrix regulatory team including generation of meeting agenda and minutes. Contribute to the generation and review of regulatory strategy documents.
• Independently manage interactions with clinical monitors, data management, safety, regulatory, and QA team members, both internally and externally in mitigations to the product release.
• Work with departmental leaderships to maintain and continuously improve an EN ISO 9001current version, ISO 13485, EN ISO 60601 versions and others.
• Participate in the Corrective Action and Preventive Action (CAPA) Review Board, internal and external audits, and training program. Make recommendations for corrective action necessary to ensure conformity with quality specifications.
• Participate in cross-functional sub-teams focused on the execution of regulatory strategy.
• Contribute to the improvement/development of department policies, procedures (RA SOPs), and best practices commensurate with the applicable requirements of rapidly growing submissions/approvals in multiply WW countries.
• Assist in managing the regulatory information management system (RIMS) and support the Quality function with the implementation of a new eQMS and in updating the current processes within QMSR.

Background profile:
• BS or MS in scientific discipline with at least 7-10 years of direct experience in Quality Assurance and Regulatory Affairs in the Medical Device industry.
• Experience leading projects in the medical device regulatory area preferred
• Strong knowledge in the FDA, and rest of the world regulatory requirements (EU/UK Regulations, ICH Guidelines, Common Rule, 21 CFR 56, 45 CFR 46 ; ISO 13485, 21 CFR 820, 21 CFR Part 10, 21 CFR Part 11; GMP, GLP, GCP, CMC, Compliance, FDAC Act, IND, CTD, NDA, PDUFA).
• Knowledge of GMP and GCP regulations and clear understanding of the Medical Device product requirements
• Experience with clinical data release operations
• Ability to find creative solutions to issues impacting timelines and budgets
• Working experience with CAPAs and internal audit systems
• Detail & deadline oriented; well organized
• Excellent verbal & written communication skills
• Good interpersonal skills; ability to interact with staff on all levels
• Strong organizational and demonstrated problem-solving capabilities
• Ability to thrive in a busy environment and maintain a positive attitude under pressure
• Works independently with minimal supervision
• Superior leadership, facilitation, and communication skills

Tagged as: CAPA, CFR, clinical, compliance, FDA, GMP, ISO, patient

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ByTRIAD Recruiting TeamMay 2, 2024

About the Author:

Avatar The TRIAD Recruiting Team is comprised of technical recruiters specializing in the engineering disciplines. TRIAD Engineering Corp. (www.triad-eng.com) is an engineering staffing firm based in Lynnfield, Massachusetts that connects successful firms with technical talent throughout Massachusetts, New Hampshire and Rhode Island. For almost 50 years, TRIAD has provided clients with flexible staffing arrangements including contract, contract-to-direct, and direct placement services.