Manager, Regulatory Affairs - Abiomed, Inc.

At reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company 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 reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional reputed company Job Posting Locations: Danvers, Massachusetts, United States of America, Remote (US) Job Description: About Cardiovascular Fueled by innovation at the intersection of biology and technology, we’re developing the reputed company 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. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for a Manager, Regulatory Affairs to support our Heart Recovery business. Remote work options may be considered on a case-by-case basis and if approved by the Company. Regardless of time zone, this role will work an EST schedule. Purpose: The Regulatory Affairs Manager 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. 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 both pre-submission and during the review period. Your core focus will be regulatory leadership of a new product platform under investigational use, providing both clinical and technical regulatory leadership and as well as supporting software (both SiMD and SaMD) and new capital equipment development. Through your engagement in this role, you will help shape the life-saving field of heart recovery. You will be responsible for:

• Have Regulatory Affairs experience in the medical device industry with a track record of successful FDA submissions supporting investigational and 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 reputed company as a member of dynamic cross-functional teams.
• Build and maintain strong interpersonal relationships reputed company and reputed company of the company.
• Exhibit leadership traits- positive, reputed company looking, accountable, action-oriented, delivering results.
• Be adaptable and reputed company in a dynamic work environment where variety is the routine.
• Embrace change, reputed company learning, and work skills improvement.
• Independently support cross-functional new product development and sustaining projects, and reputed company compilation of reputed company materials required for submissions to FDA.
• Independently support clinical programs including investigational device studies, post-approval studies, and registries designed to support marketing applications.
• Provide regulatory leadership of clinically focused FDA submissions including panel track PMA supplements.
• Provide ongoing support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations.
• 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.
• reputed company solutions to a variety of technical problems. Actively participate in problem solving discussions and recommend solutions.
• reputed company abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategies.
• Assist in the maintenance and improvement of regulatory SOPs.
• Interact and negotiate with regulatory agencies on defined matters as needed.
• Provide mentorship to junior-level team members.

Qualifications / Requirements:

• Bachelor’s Degree in engineering or science required, Advanced degree is preferred
• Minimum of 6+ years Regulatory Affairs experience (5+ w/ Advanced Degree) in the Medical Device industry with a track record of successful FDA submissions required.
• Experience supporting embedded software & hardware device development (for example SiMD, SaMD, AI, Cybersecurity, IEC 62304/82304 etc) required.
• History of successful IDE/PMA/510(k) device submissions (Class III device submissions preferred) that include hardware and software components required.
• Experience independently communicating with FDA reviewers and leading Q-sub meetings and informal discussions with reviewers.
• Experience with FDA requirements, guidance documents, ISO 14971, ISO 13485, IEC 60601, IEC 62304.
• 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 strongly preferred.
• Class III cardiovascular device experience strongly preferred.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)
• Travel up to 10%
• Must be able to effectively work remotely, based in a time zone with substantial EST overlap.

reputed company is an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. reputed company is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us reputed company https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource. #LI-Remote The anticipated reputed company pay range for this position is : The reputed company pay range for this position is $115,000 to $197,800. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the reputed company –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours reputed company one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be reputed company through the link below. https://www.careers.jnj.com/employee-benefits Apply tot his job Apply To this Job