Senior Regulatory Affairs Program Lead - 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. Learn more at https://www.jnj.comJob Function:Regulatory Affairs GroupJob Sub Function:Regulatory AffairsJob Category:ProfessionalAll Job Posting Locations:Austin, Texas, United States, Dallas, Texas, United States, Danvers, Massachusetts, United States of America, Houston, Texas, United States of AmericaJob Description:We are searching for the best talent for a Senior Regulatory Affairs Program Lead. This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.Purpose : In joining our growing regulatory team, the Sr. Regulatory Affairs Program Lead will help Abiomed reach US and international regulatory (NPD) approval goals. Under minimal supervision, the selected candidate will be working on the portfolio RA needs, working closely with exceptional engineering and clinical teams, as well as supporting product development stages and generating submission ready documentation and authoring regulatory submissions. Additionally, this individual will support health authority communications and participate in strategy development.Key Responsibilities:• Instills and drives a vibrant regulatory culture, working among cross functional groups as a teammate and collaborator.• Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals.• Prepares and submits regulatory information required to obtain global market access, with focus on US. This including preparation, writing and filing of FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s, PMAs, PMA Supplements).• Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams. This includes conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission.• Proactively identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status.• Conduct regulatory evaluation of changes to devices in accordance with requirements of commercial/operating geography and generate the required regulatory submission (including Letters To File)• Guides conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials.• Assists in the development of Regulatory Affairs processes.Qualifications/Requirements:• Minimum of a Bachelor's Degree required, Advanced Degree highly desired ; desired areas of study include Science, Engineering, or related field.• Minimum of 6+ years of related Regulatory Affairs experience within Medical Device is required (4+ years with Advanced Degree).• Experience with Class III medical device regulatory new product submissions required.• A demonstrated track record of developing and driving implementation of regulatory strategies.• Working knowledge of Cybersecurity regulations, requirements for software as a medical device, including devices with AI/ML.• Working knowledge of requirements for medical devices that include electronic components and associated testing (IEC 60601).• Working knowledge of how FDA regulations impact product registration.• Good communication skills for effective collaboration with cross-functional partners.• Corresponding and collaborating with J&J colleagues globally for strategic contribution and achievement of regulatory milestones.• Evaluating new regulatory requirements as well as regulatory changes and correctly assessing business impact.• Excellent verbal and written communication skills; strong attention to detail.• Advanced analytical and problem-solving skills.• High organization skills with the ability to lead multiple projects/tasks simultaneously and effectively prioritize projects and tasks.• Strong learning skills for complex technology and presentation skills to allow presentation of complex regulatory strategies in a clear, concise, and comprehensive fashion.• This position will require up to 10% travel.• Previous experience with health authority meetings/interactionsJohnson & 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. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.Johnson and Johnson 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.The anticipated base pay range for this position is :The anticipated base pay range for this position is $104,000 to $166,750.Additional Description for Pay Transparency: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: o Vacation – up to 120 hours per calendar year o 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 o 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