Regulatory Affairs Director jobs in Santa Rosa, CA

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

• Represents the Regulatory Affairs function on product development teams, bringing the voice of the function to discussions in an effort to support creative and compliant regulatory strategies for the program.
• Partners with cross-functional team members to lead engagements with regulatory agencies for new and existing devices.
• Leads and influences the preparation of documentation to support innovative and high-quality regulatory submissions from early phase strategies, marketing applications, and change management implementation.
• Engage and actively participate in compliance activities (preparation and execution) including identification of opportunities for improved efficiencies within processes. 
• Acts as a mentor to colleagues within the team and effectively manages an extended team.
• Stays current on regulation and guidance changes supporting advocacy work as needed to influence evolving regulatory requirements.
• Works with functional team members to ensure clear communication of project/program objectives, deliverables, and timing of key milestones. 
• Partners in problem resolution in an effort to mitigate functional/ program level challenges to keep objectives moving in line with program estimates.
• Works within a matrixed, collaborative team environment that fosters professional development while focusing on meeting business objectives driven by standards of excellence.

Must Have (minimum requirements)

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

•  Bachelor’s degree.
• Minimum of 7 years of direct Regulatory Affairs experience within the medical device industry
• Or advanced degree with a minimum of 5 years of Regulatory Affairs experience within the medical device industry 

Desired/Preferred Qualifications  

• Direct Regulatory Affairs experience supporting programs throughout software development life cycle.
• Medical device industry experience with Class II/III/IV products.
• Experience supporting software device development (for example SiMD, SaMD, AI, Cybersecurity, IEC 62304/82304 etc.,) and associated regulatory filings in the U.S., EU, and globally.
• Experience performing advertising and promotion reviews/approvals for medical devices.
• Experience engaging regulatory bodies.
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
• Analytical, process and data visualization experience  
• Working knowledge of Project Management methodologies and tools; PMP certification is an asset. 
• Demonstrated strong business acumen and planning. 
• Strong interpersonal, quantitative analysis, and problem-solving skills. 
• High degree of initiative and influence management skills
• Excellent written and oral communication, technical writing, and editing skills.
• Experience working in a virtual team environment in supporting cross-functional teams remotely.  
• Results oriented. Ability to drive to completion in adherence to aggressive project schedules. 
• Ability to manage multiple projects and proficiency with Microsoft Office and software tools.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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.