Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)
Principal Regulatory Affairs Specialist - Structural Heart and Aortic, Mitral and Tricuspid (hybrid)
Come be a part of one of the most exciting therapy areas within Medtronic, supporting the Transcatheter Mitral and Transcatheter Tricuspid (M&T) programs within the. The M&T space is one of the fastest growing businesses in the medical device industry and is expanding rapidly to serve patients globally. To meet this need, we are adding to our world-class M&T Regulatory Affairs team and looking to hire a Principal Regulatory Affairs Specialist to make an immediate impact for patients with our novel, breakthrough technologies.
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
Join a diverse team of Regulatory Affairs Professionals who bring their knowledge, their unique backgrounds, and experiences to work every day. It’s no accident —we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
The preference is for this position to be based in Santa Rosa, CA or Mounds View, MN.
Careers that Change Lives
Reporting to the Senior Manager, the Principal Regulatory Affairs Specialist will support Research and Development programs with early phase pre-market regulatory strategy development with a view through the full product lifecycle. The Prin. RA Specialist will execute regulatory filings to support this strategy such as FDA Pre-Submissions, PMDA Consultations, IDEs, PMAs, 510(k)s, Technical Files, etc. Being a driven individual and strong communicator is key for this role and the successful candidate should be comfortable working in novel areas to ensure projects continue to gain momentum and meet milestones. Ideally, this candidate will have experience supporting software development programs, at minimum software in a medical device (SiMD) with proficient working knowledge of cybersecurity and interoperability requirements.
Additionally, the Principal Regulatory Affairs Specialist is expected to play a key role in the mentoring of junior team members and to be an active participant in the development and training of the Regulatory Affairs team. The individual will work in collaboration with Regulatory Affairs Team members, cross functional members at varying levels within the organization as well as International Regulatory Affairs staff. Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre-submissions, PMDA consultations, original IDEs and PMAs, IDE and PMA Supplements/Reports, Shonin applications, and EU MDR Technical Documentation in addition to Change Management assessments. The successful candidate will actively support advertising and promotion activities for commercial products across the portfolio, may support audit and compliance activities as needed and support business development activities/needs as they arise. Candidates that will be successful in this role thrive in a dynamic and priority driven environment that requires creative strategies fostered by a culture that encourages close collaboration with colleagues, new approaches that yield constructive, unconsidered insights and ability to mentor and develop more junior members of the team.
A Day In The Life
Must Have (minimum requirements)
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Desired/Preferred Qualifications
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here.
The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
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