Experience Inc. Jobs

Regulatory Affairs Manager - 2406202018W

Description

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

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. Learn more at https://www.jnj.com/

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.

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 pre-submission and during the review period. Your core focus will be regulatory leadership 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:

• Independently 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:

• BS Degree in engineering or science required

• Advanced degree is preferred

Required:

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

• Minimum of 6 years Regulatory Affairs experience with a Bachelor's degree or Minimum of 5 years Regulatory Affairs experience with an advanced degree

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

• Experience independently communicating with FDA reviewers and leading Q-sub meetings and informal discussions with reviewers

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

• 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 August 1, 2024, the company may however extend this time-period.

The anticipated base pay range for this position is $113,000 to $170,000. California Bay Area $139,000 to $195,500. The anticipated base pay range for this position is. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be 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.

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

• Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market

Primary Location NA-US-4887-Danvers

Organization ABIOMED Inc.(6942)

Job Function Regulatory Affairs

Req ID: 2406202018W