We anticipate the application window for this opening will close on - 27 Jun 2025

 

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

SENIOR REGULATORY AFFAIRS SPECIALIST

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

Saving lives for us is not just a cliché but is part of our everyday DNA.   Real people with debilitating conditions can now be given back active lives through the restorative therapies that we provide.  Therefore, we are looking for passionate engineers who are excited about working in the software field and testing revolutionary mobile and web-based applications that directly affect and improve patient’s lives. 

The Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners, and global regulatory agencies to introduce products and changes to market, provides advice on regulatory requirements, prepares submissions and negotiates their approval.  The Senior RA Specialist also assists with the license maintenance including annual reports, renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations.

Neuroscience Portfolio

The Neuroscience Portfolio group develops life-restoring therapies and healthcare solutions that span the neurological care continuum including integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.  The software that we produce supports the following areas:

Spinal Cord Stimulation: https://www.medtronic.com/us-en/healthcare-professionals/products/neurological/spinal-cord-stimulation-systems.html

Deep Brain Stimulation: https://www.medtronic.com/us-en/healthcare-professionals/therapies-procedures/neurological/deep-brain-stimulation.html

Sacral Neuromodulation : https://www.medtronic.com/us-en/healthcare-professionals/therapies-procedures/urology/sacral-neuromodulation.html

Targeted Drug Delivery: https://www.medtronic.com/us-en/healthcare-professionals/therapies-procedures/neurological/targeted-drug-delivery.html

Career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. Medtronic offers award-winning programs to accelerate your development and growth. Our size, scope and market leadership give you the chance to explore career opportunities  and grow as we grow. 
 

A Day In The Life

• Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
• Collaborate with marketing and medical education groups on claims for new promotional materials.
• Review and approve advertising, promotional and educational materials for compliance with regulatory requirements.
• Apply regulatory and therapeutic area knowledge to marketing objectives and initiatives to develop solutions to complex US promotional issues.
• Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
• Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, product recalls, etc., as needed.
• Provide business and product information to international regulatory staff to enable development of strategies and requirements, and communicate that information to business teams.
• Provide feedback and on-going support to product development teams for regulatory issues and questions. 
• Prepare FDA, European and Canada submissions for product changes as required to ensure timely approval for market release.  Review significant regulatory issues with manager, as necessary, and resolve submission issues with engineering partners,  geography regulatory partners, and regulatory agencies as needed.
• Prepare regulatory strategies/plans and compliance requirements.  Provide on-going support to project teams for regulatory issues and questions. 
• Provide regulatory support for currently marketed products.  This includes reviewing labeling and changes to existing devices and documentation.  Prepare submissions and reports for regulatory agencies as required.
• Provide training and support to other members of the department.

Must Have; Minimum Requirements

• Bachelor’s degree in a scientific discipline or equivalent with 4 years of relevant experience or an Advance degree with 2 years of experience

Nice To Have 

• 5-8 years industry experience
• At least 2-3 years regulatory, clinical, quality experience
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences)
• Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA, EU Notified Body), and working with cross-functional project teams.     
• 4+ years medical device industry experience 
• In depth experience with FDA requirements, guidance documents, Active Medical Device Directive/EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards 
• Experience with Class III medical devices (PMA)
• History of successful device submissions
• Strong negotiation skills and written/oral communication skills
• Strong organizational skills and time management skills
• Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
• Ability to work independently and under general direction only 
• Computer skills; MS Office, MS Project, Adobe Acrobat and Agile 

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.
 

Salary ranges for U.S (excl. PR) locations (USD):$92,000.00 - $138,000.00

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, 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.