Sr. Regulatory Affairs Specialist
Medtronic
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.The Senior Regulatory Affairs Specialist role will both lead and support the review of advertising and promotional materials for MiniMed diabetes products across Europe, the Middle East, and Africa (EMEA), plus the UK and Ireland. This role ensures compliance with regional regulations, working closely with cross-functional teams (marketing, clinical, and international regulatory colleagues, consulting with legal when needed) to enable innovative and compliant product communication.
A remote based position in country or from the United States is possible, with travel to onsite meetings in North America about twice per year.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Key responsibilities may include the following and other duties may be assigned.
Review and approve EMEA and UKI advertising and promotional materials for diabetes products ensuring compliance with local, regional, and international regulations.
Collaborate with regulatory, legal, marketing, and international regulatory teams to ensure clarity and accuracy of promotional claims.
Work with Medical Affairs to confirm and align claims according to clinical trial publications and clinical data.
Advise on regulatory requirements and best practices for product advertising and promotion in EMEA.
Monitor global regulatory changes and trends and competitor activity, proactively communicating changes to internal teams and contribute to updating processes.
Coordinate with regulatory specialist teammates’ submissions and required documentation related to indications for use, regulator interactive review, etc.
Provide training and guidance to internal stakeholders on regulatory standards and company risk tolerance for advertising and promotion.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Bachelor’s degree in a scientific, healthcare, or regulatory-related field and 4+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.
OR
Advanced Degree in a scientific, healthcare, or regulatory-related field and 2+ years of regulatory affairs experience, preferably with medical device submissions, registrations or advertising and promotional review.
Nice to Have
Advanced degree (Master’s or equivalent).
Experience with diabetes-related products or devices.
4+ years of U.S. and EU regulatory submission experience (preferred 510(k) and Technical Documentation)
Proficient understanding of EU MDR, FDA requirements.
Knowledge of Medical Device Quality Systems
Experience working with international, cross-functional, and core-teams.
Product launch experience.
Understanding of corporate goals, product pipeline, disease state, customer needs, reimbursement, and competitive environment.
Experience with Agile, Veeva PromoMats.
Demonstrated experience in reviewing advertising and promotional materials in either Europe, United States, or Canada (EMEA experience preferred).
Strong knowledge of medical device regulations, including EU MDR, UK MHRA, US FDA and /or regional advertising standards.
Ability to interpret clinical data and publications in the context of promotional claims.
Exceptional attention to detail and strong communication skills.
Experience collaborating in cross-functional and international teams.
Strong oral and written communication skills.
Effective interpersonal skills.
Effective team member.
Proficient skills with MS Word, MS Outlook, MS Excel, MS PowerPoint.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
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.
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, and 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), and 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
About Medtronic
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.
Learn more about our business, mission, and our commitment to diversity here.
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.
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 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.