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PSG Global Solutions
Cambridge, MA, United States
Description We're looking for a Manager of Regulatory Affairs , working in Biotechnology/Medical Devices industry in Cambridge, Massachusetts, United States . Works with Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Develop
Job Source: PSG Global SolutionsFoundation Medicine
Boston, MA, United States
About the Job The Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. The incumbent functions as the regulatory representative on cross-func
Job Source: Foundation MedicineHiring Now!
Boston, MA, United States
About the Job The Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. The incumbent functions as the regulatory representative on cross-funct
Job Source: Hiring Now!Deciphera Pharmaceuticals
Watertown, MA, United States
Company Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.
Job Source: Deciphera PharmaceuticalsApogee Therapeutics
Boston, MA, United States
Role Summary We are seeking a Manager, Regulatory Affairs. This newly created role offers an opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly. Reporting to the Executive Director of Regulatory Affairs, you will have the opportunity to oversee the imp
Job Source: Apogee TherapeuticsDeciphera Pharmaceuticals
Watertown, MA, United States
Company Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.
Job Source: Deciphera PharmaceuticalsBioTalent
Norwood, MA, United States
Introduction BioTalent is representing a top-tier life sciences device manufacturer hiring a Regulatory Affairs Manager ensure compliance with global regulatory requirements while managing the regulatory affairs team. The role requires collaboration with product development, quality assurance, and other cross-functional teams to support the organiz
Job Source: BioTalentDeciphera Pharmaceuticals, Inc
Waltham, MA, United States
Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. Enabled by our propr
Job Source: Deciphera Pharmaceuticals, IncWatertown, MA, United States
QUALIFICATIONS:
- BS or MS in a scientific discipline with 7-10 years of direct experience in Quality Assurance and Regulatory Affairs within the Medical Device industry
- Strong knowledge of FDA and global 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)
- Proficiency in GMP and GCP regulations with a clear understanding of Medical Device product requirements
- Ability to find creative solutions to issues impacting timelines and budgets
- Experience with CAPAs and internal audit systems
- Detail-oriented, well-organized, and deadline-driven
- Excellent verbal and written communication skills
- Strong interpersonal skills and the ability to interact with staff at all levels
- Exceptional organizational and problem-solving abilities
- Ability to thrive in a fast-paced environment and maintain a positive attitude under pressure
- Capable of working independently with minimal supervision
- QA/RA: 7 years (Required)
- Location: Watertown, MA 02472 (Required)
RESPONSIBILITIES
- Report to the VP of Quality Assurance and Regulatory Affairs
- Collaborate with the company’s cross-functional team to ensure the new product line meets technical, clinical, and market standards
- Create and manage a product/project database to document the history of the DermaTemp (DT) medical device product release and ongoing maintenance
- Develop release plans for the product line, 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
- Coordinate with cross-functional departments to prepare documentation necessary for submitting applications (MDD to MDR) to the EU Notify Body
- Support the VP of QA/RA in driving 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 feedback to ensure accurate and complete documents for 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, both internally and externally, to support product release
- Work with departmental leadership to maintain and continuously improve EN ISO 9001, ISO 13485, EN ISO 60601, and other standards
- Participate in the Corrective Action and Preventive Action (CAPA) Review Board, internal and external audits, and training programs
- Recommend corrective actions necessary to ensure conformity with quality specifications
- Participate in cross-functional sub-teams focused on executing regulatory strategy
- Contribute to the improvement and development of department policies, procedures (RA SOPs), and best practices in line with the growing number of submissions and approvals worldwide
- Assist in managing the regulatory information management system (RIMS) and support the Quality function with implementing a new eQMS and updating current QMSR processes
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Email Alert for Regulatory Affairs Manager jobs in Watertown, MA, United States
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