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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
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Senior Regulatory Affairs Specialist. Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices.
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Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society) Regulatory affairs experience in the medical device industry with a track record of successful submissions.
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Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance. You will advise on regulatory requirements as a key member of cross-functional teams, prepare and review FDA submissions, and interact with and respond to FDA pre-submission and during the review period.
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Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance. Provide support for changes to existing products, including providing regulatory assessment of changes, and subsequent regulatory filings.
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Provide ongoing support to project teams for regulatory issues and questions. Interact and negotiate with regulatory agencies on defined matters as needed. Assist in the maintenance and improvement of regulatory SOPs.
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Be energized by joining a world-class company and regulatory team. Strong communication and regulatory writing skills. Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives.
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Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation. Abiomed's "Patients First!" Remote work options may be considered on a case-by-case basis and if approved by the Company.
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Ability to comprehend principles of engineering, physiology and medical device use. Support cross-functional new product development projects and lead compilation of all materials required for submissions to FDA.
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Keep abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategies. Through your engagement in this role, you will help shape the life-saving field of heart recovery.
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For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $104,000 to $140,000. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
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Exhibit leadership traits- positive, forward looking, accountable, action-oriented, delivering results. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before.
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Location field must contain 'city, state' or a zip code to perform a radius search (e.g., Embrace change, continuous learning, and work skills improvement. Adaptable and thrive in a dynamic work environment where variety is the routine.
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Culture drives our skilled workforce and strong relationships with clinicians. Enjoy teamwork and thrive as a member of dynamic cross-functional teams. Strong problem solving skills, interpersonal skills and effective team member.
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Actively participate in problem solving discussions and recommend solutions. Must be able to effectively work remotely. Find, interpret and apply regulations and guidance appropriately for situations. The Company maintains highly competitive, performance-based compensation programs.
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Title: associate director regulatory affairs Company: Modalis Therapeutics
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