- 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.
- 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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Regulatory Manager - Waltham, United States - BostonGene
Description
Position Summary
BostonGene 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
Qualifications
About BOSTONGENE
BostonGene Corporation is pioneering the use of biomedical software for advanced patient analysis and personalized therapy decision-making in the fight against cancer. BostonGene's unique solution performs sophisticated analytics to aid clinicians in evaluating viable treatment options for each patient's individual genetics, tumor and tumor microenvironment, clinical characteristics, and disease profile. BostonGene's mission is to enable physicians to provide every patient with the highest probability of survival through optimal cancer treatments using advanced, personalized therapies via sophisticated analytics and the integration of scientific and clinical knowledge.
