Senior Regulatory Affairs Specialist

Sacramento, CA, United States

J&J Family of Companies Senior Regulatory Affairs Specialist Sacramento , California Apply Now Senior Regulatory Affairs Specialist - 2406193618W

Description

Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. Remote work options may be considered on a case-by-case basis and if approved by the Company

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. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. 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. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

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. 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. Your core focus will be regulatory support for software (both SiMD and SaMD) and hardware development and changes. Through your engagement in this role, you will help shape the life-saving field of heart recovery.

The ideal candidate will:

Have Regulatory Affairs experience in the medical device industry with a track record of successful FDA submissions that include software and hardware components

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

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

Key Responsibilities:

Support cross-functional new product development projects with a specific focus on software (both SiMD and SaMD) and hardware aspects, and lead compilation of all materials required for submissions to FDA

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

Develop solutions to a variety of technical problems. Actively participate in problem solving discussions and recommend solutions

Keep 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

Qualifications

Education

Bachelor’s Degree in engineering or science required

Advanced degree is preferred

Required

Minimum of 4 years Regulatory Affairs experience with a Bachelor's degree or minimum of 3 years Regulatory Affairs experience with an advanced degree

History IDE/PMA/510(k) device submissions that include hardware and software components (Class III device submissions preferred)

Regulatory Affairs experience in the medical device industry with a track record of successful FDA submissions

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

Preferred

Ability to comprehend principles of engineering, physiology and medical device use.

Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)

Other

Travel up to 10%

Must be able to effectively work remotely

This job posting is anticipated to close on 7.4.2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $104,000 to $140,000. The Company maintains highly competitive, performance-based compensation programs. Additional information can be found through the link below. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

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