- Regulatory Affairs knowledge
- Quality Management system knowledge
- 510K submissions
- Clinical submissions and trials
- MDR (Medical Device Reporting)
- ISO
- EU requirements
- MDSAP (Medical Device Single Audit Program)
- Auditing experience is desired but not required.
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Quality & Regulatory Project Manager (Medical device industry) - Boston, United States - Client of terconsultingma
Description
Job Description
Job DescriptionThis well-established organization located West of Boston has an immediate need This job is 100% onsite and has no flexibility.
Only resumes that qualify for the job will be notified. US citizen or Green card only Will not sponsor any Visa referrals
Reports to VP of Quality Assurance and Regulatory Affairs.
Key Responsibilities and Activities:
· This position will be managing the new product line. The QA/RA manager will collaborate with the company's cross-functional team to bring the new product line within technical, clinical, and market-applicable standards.
· Create and manage product/project database to record the DermaTemp (DT) medical device product release history 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 to prepare the documentation necessary to submit applications (MDD to MDR) to the 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, and 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 generating meeting agendas 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 internally and externally in mitigations to the product release.
· Work with departmental leadership to maintain and continuously improve the EN ISO 9001 current 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 improving/developing department policies, procedures (RA SOPs), and best practices commensurate with the applicable requirements of rapidly growing submissions/approvals in multiple WW countries.
· Assist in managing the regulatory information management system (RIMS) and support the Quality function by implementing a new eQMS and updating the current processes within QMSR.
Required Education and Experience:
· BS or MS in a 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 a 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
NOTES:
Here is the list of the required skills for the DT product manager – the resume needs to show all of these or at least most:
This is not a quality role – it is mostly regulatory so the experience should be pretty solid
