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Regulatory Manager (Waltham, MA)
Position Summary
Client is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular techniques, including MXIF, IHC, Flow cytometry, and DNA and RNA sequencing (exome).
Responsibilities
Client is seeking a Regulatory Manager to join our team and play a crucial role in supporting our ISO certification efforts and regulatory compliance. The primary focus of this position will be on ensuring Good Laboratory Practice (GLP) and ISO conversion for a team dedicated to assisting cancer patients using various molecular techniques, including MXIF, IHC, Flow cytometry, and DNA and RNA sequencing (exome).
Responsibilities
- Develop and implement regulatory strategies and processes to ensure compliance with ISO standards and Good Laboratory Practice (GLP) requirements.
- Provide strategic and tactical regulatory guidance to influence project planning and decision-making processes positively.
- Develop clinical and commercial regulatory strategies for assigned products to facilitate successful study designs and timely registration with regulatory health authorities.
- Collaborate with internal teams and diagnostic partners to align on co-development regulatory needs and expectations, including regulatory submissions (e.g., PMA, 510(k), IDE).
- Prepare for and facilitate meetings with regulatory agencies in collaboration with diagnostic partners and internal teams.
- Review and approve key diagnostic regulatory submissions to CDRH and global health authorities, as agreed upon with diagnostic partners.
- Interact with international regulatory colleagues and diagnostic partners to determine best practices and regulatory paths for development and global registration activities.
- Assess the impact of relevant regulations on drug and diagnostic development and registration activities.
- Provide regulatory support for due diligence activities related to external diagnostic companies.
- PhD and/or MS degree preferred within Regulatory Affairs, Life Sciences, or Engineering.
- CLIA/CAP/NYS experience is required.
- 6 plus years of experience in Regulatory Affairs, including United States and international medical device and/or IVD/CDx regulations.
- 8 plus years of experience in medical device and/or IVD/CDx industry.
- Proven experience in effectively communicating and working with US FDA, Competent Authorities, and other regulatory agencies.
- Regulatory submissions experience.
- Must be detail oriented, well-organized, and able to work both independently and in teams.
- Exceptional written and strong verbal communication skills.
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