Senior Regulatory Affairs Specialist_

Sacramento

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

* Experience supporting software device development (for example SiMD, SaMD, AI, Cybersecurity, IEC 62304/82304 etc

* 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.

* Class III cardiovascular device experience

* 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 areers.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: areers.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.

**Primary Location** NA-US-4887-Danvers

**Other Locations** NA-United States

**Organization** ABIOMED Inc.(6942)

**Job Function** Enterprise Compliance

**Req ID:** 2406193618W