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Associate - Medical Devices, FDA Regulatory
The candidate will... join the FDA Medical Devices group to... and responsibilities include: researching FDA medical device regulatory issues,... as preparing responses to FDA premarket review and post... Prior work experience with FDA device matters is desired.... FDA...
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in-house in a biotechnology company and law firm practice is ideal. Significant experience counselling on consumer protection matters is a plus. Should preferably have experience with FTC, FDA and trade compliance matters.... Solid understanding of biotech compliance matters are plus....
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Counsel, Contracts
Duties: Provides transactional legal support to the Research and Development organizations and other departments in conjunction with senior members of the Legal team. Draft, review and negotiate a wide range of contracts in support of the Research and...
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and legal direction on FDA labeling and promotional matters,... and other clients on FDA regulatory submissions, label negotiations... and privacy and data use. Counseling on appropriate relationships with healthcare professionals, patients, managed care entities, academic institutions, and government entities. Developing...
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Commercial Counsel – Diabetes Care
Duties: Provide legal support for an exciting variety of commercial health care and digital health projects at Diabetes Care, including: Collaborating with global stakeholders in all areas of the business to support strategic plans for...
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Counsel
Duties: In close collaboration with other team members, strategically develop worldwide patent portfolio, including directing and managing domestic and foreign outside counsel to prepare and prosecute patent applications in a diverse and growing technological field; participate in the effective...
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responsible for counseling on FDA laws, regulations, and guidance... documents with respect to complex regulatory issues relating to the development, approval, and marketing of medical devices; product cybersecurity; lifecycle management; as well as inspectional and product safety/quality issues. Collaborates with...
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and industry codes (FDCA, FDA guidance Documents, Fraud and... Abuse laws, Anti-kickback Statute, federal and state transparency laws, OIG Advisory Opinions, FCPA, etc.). Serve as the legal representative on cross-functional therapeutic area Promotional Review Committees to provide legal feedback and...
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non-proprietary name submissions to FDA, EMA, WHO and other... agencies. Draft and oversee filing of US trademark prosecution documents. Manage ex-US prosecution and dispute dockets, including timely attention to deadlines and oversight of paralegal trademark prosecution and maintenance responsibilities. Review...
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