Sr Prin Regulatory Affairs Spec in City of Westminster

The Senior Principal Regulatory Affairs Specialist will provide strategic regulatory leadership for multiple complex product development programs, with a particular focus on AI-enabled technologies.

This role is responsible for developing and executing global regulatory strategies, leading the planning, preparation, and submission of high-quality regulatory filings, and ensuring alignment with evolving regulatory expectations for innovative digital and AI-driven solutions.

The individual will manage multiple workstreams, collaborate closely with cross-functional partners, and proactively identify and mitigate regulatory risks to support timely approvals and successful market access.

This position is intended for an experienced regulatory professional who can operate with a high degree of independence, while managing concurrent projects, influence strategy across programs, and help build long-term regulatory capability within the organization.

Responsibilities may include the following and other duties may be assigned.

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.
• Experience in software, cybersecurity, and AI/ML related regulatory submissions.
• Bachelors degree required
• Minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience.
• Nice to Have
• Experience with FDA pre-determined change control plan (PCCP) submissions.
• Clinical trial submissions.
• Regulatory review of advertising and promotion materials.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C. F. R. § 214.2(h)(4)(iii)(A) is required.

Careers that change lives start here.

Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life.

Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year.

Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here https://www. medtronic. com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice. pdf a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.

We are engineers at heart - putting ambitious ideas to work to generate real solutions for real people.

From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves.

We have the talent, diverse perspectives, and guts to engineer the extraordinary.

We change lives .

Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes.

Our industry leadership comes from the passion and ingenuity of our people.

That's who we are.

Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team .

With one Medtronic Mindset defining how we work.

• By bringing your ambitious ideas, unique perspective and contributions, you will…
• Build a better future, amplifying your impact on the causes that matter to you and the world
• Grow a career reflective of your passion and abilities
• Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest: Experiences that put people first.

Respect for people is the hallmark of our humanity.

It fuels our team to positively impact even a single life.

And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world .

Here, it's about more than the bottom line.

Our Mission to improve human welfare drives us.

We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care .

Fresh viewpoints.

Cutting-edge AI, data, and automation.

You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.

In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

Medtronic offers a competitive Salary and flexible Benefits Package.

Salary ranges for U.

S (excl.

PR) locations (USD):$157,600.00 - $236,400.00 Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: United

Kingdom: 87,280.00 GBP - 130,920.00 GBP | This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California.

The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.

Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week:

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• The following benefits and additional compensation are available to all regular employees:
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Regular employees are those who are not temporary, such as interns.

Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below: Medtronic benefits and compensation plans (https://www3. benefitsolver. com/benefits/Benefit Solver View?page_name=signon&co_num=30601&co_affid=medtronic)

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