Johnson & Johnson MedTech
Senior Regulatory Affairs Specialist - Abiomed, Inc.
Johnson & Johnson MedTech, Danvers, Massachusetts, us, 01923
Senior Regulatory Affairs Specialist - Abiomed, Inc.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Job Function : Regulatory Affairs Group Job Sub Function : Regulatory Affairs Job Category : Professional All Job Posting Locations : Danvers, Massachusetts, United States of America Job Description About Cardiovascular: Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. We are searching for the best talent for a
Senior Regulatory Affairs Specialist
to support our Abiomed business. This role will work a Flex/Hybrid schedule and be based in the Danvers, MA office. There is NO remote option and relocation assistance is not provided. Purpose : The Senior Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Abiomed. You Will Be Responsible For Prepare and submit regulatory documents, including applications for product registrations, amendments, annual renewals, and post-market surveillance reports, to respective health authorities (e.g. US FDA, Health Canada). Collaborate with regional regulatory partners as needed in preparing submissions for global expansion. Evaluate proposed changes for regulatory impact and perform any required regulatory submissions/amendments. Maintenance of licenses throughout product lifecycle. Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes in responsible jurisdictions. Provide regulatory support for internal and external audits (e.g. MDSAP). Monitor and anticipate changes in regulations in responsible jurisdictions. Prepare regulatory documents (e.g. CFG) to support global expansions or tenders. Have Regulatory Affairs experience in the medical device industry with a track record of successful Canada, LATAM or US FDA submissions supporting commercial medical devices. Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art Class II and class III cardiovascular medical devices. Be energized by joining a world-class company and regulatory team. Enjoy teamwork and thrive as a member of dynamic cross-functional teams. Build and maintain strong interpersonal relationships within and outside of the company. Exhibit leadership traits- positive, forward looking, accountable, action-oriented, delivering results. Be adaptable and thrive in a dynamic work environment where variety is the routine. Embrace change, continuous learning, and work skills improvement. Able to manage multiple competing priorities. Qualifications / Requirements Minimum of a Bachelor’s Degree required, Advanced degree is strongly preferred. Science or Engineering discipline highly desired. At least 2+ years of related professional Regulatory Affairs experience required (1+ with Advanced Degree). Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance. Ability to effectively manage multiple projects and priorities. Strong communication and regulatory writing skills. Strong problem solving skills, interpersonal skills and effective team member. Results oriented. Ability to drive to completion in adherence to aggressive project schedules. Ability to comprehend principles of engineering, physiology and medical device use preferred. Class III cardiovascular device experience preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society). Travel up to 10%. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. The anticipated base pay range for this position is $89,000 to $143,750.
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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Job Function : Regulatory Affairs Group Job Sub Function : Regulatory Affairs Job Category : Professional All Job Posting Locations : Danvers, Massachusetts, United States of America Job Description About Cardiovascular: Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. We are searching for the best talent for a
Senior Regulatory Affairs Specialist
to support our Abiomed business. This role will work a Flex/Hybrid schedule and be based in the Danvers, MA office. There is NO remote option and relocation assistance is not provided. Purpose : The Senior Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Abiomed. You Will Be Responsible For Prepare and submit regulatory documents, including applications for product registrations, amendments, annual renewals, and post-market surveillance reports, to respective health authorities (e.g. US FDA, Health Canada). Collaborate with regional regulatory partners as needed in preparing submissions for global expansion. Evaluate proposed changes for regulatory impact and perform any required regulatory submissions/amendments. Maintenance of licenses throughout product lifecycle. Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes in responsible jurisdictions. Provide regulatory support for internal and external audits (e.g. MDSAP). Monitor and anticipate changes in regulations in responsible jurisdictions. Prepare regulatory documents (e.g. CFG) to support global expansions or tenders. Have Regulatory Affairs experience in the medical device industry with a track record of successful Canada, LATAM or US FDA submissions supporting commercial medical devices. Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art Class II and class III cardiovascular medical devices. Be energized by joining a world-class company and regulatory team. Enjoy teamwork and thrive as a member of dynamic cross-functional teams. Build and maintain strong interpersonal relationships within and outside of the company. Exhibit leadership traits- positive, forward looking, accountable, action-oriented, delivering results. Be adaptable and thrive in a dynamic work environment where variety is the routine. Embrace change, continuous learning, and work skills improvement. Able to manage multiple competing priorities. Qualifications / Requirements Minimum of a Bachelor’s Degree required, Advanced degree is strongly preferred. Science or Engineering discipline highly desired. At least 2+ years of related professional Regulatory Affairs experience required (1+ with Advanced Degree). Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance. Ability to effectively manage multiple projects and priorities. Strong communication and regulatory writing skills. Strong problem solving skills, interpersonal skills and effective team member. Results oriented. Ability to drive to completion in adherence to aggressive project schedules. Ability to comprehend principles of engineering, physiology and medical device use preferred. Class III cardiovascular device experience preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society). Travel up to 10%. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. The anticipated base pay range for this position is $89,000 to $143,750.
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