Regulatory Affairs Specialist

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

Regulatory Affairs Specialist

I n this exciting role as a Regulatory Affair Specialist , you will have responsibility for developing and implementing compliant regulatory processes within the Surgical OU Regulatory organization.

Operating Unit

Our Surgical OU is one new, powerful operating unit bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics. We'll approach the market with a unified approach from concept single strategy, capitalize on our global commercial capabilities, and prove the power of our combined portfolio.

With the Medtronic Mission as our North Star, we will build on our legacy of proven surgical solutions and advance the promise of robotics and digital solutions for the benefit of Medtronic and the customers and patients we serve.

Careers That Change Lives

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.

Day in the Life

Responsibilities include but are not limited to the following:

• Liason with OU Regulatory to ensure accurate application of processes and assignment of data attributes
• Conversion of Technical Documents to Global Submission Summary Documentation (GSSD).
• Creation of e-BOM structure in CAP Agile for GSSD.
• Streamline Processes through use of Artificial Intelligence.
• Monitors and remains in compliance with multiple Quality Management Systems.
• Keeps abreast of regulatory procedures and changes.

Must Have: Minimum Requirements

• Bachelor’s degree in Medical, Mechanical, Life Science or other healthcare related major.
• 4-7 years experiences for RA role in medical device and or pharmaceutical industry.
• Works independently with general supervision on larger, moderately complex projects / assignments.
• Contributes to the completion of project milestones.
• Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
• Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues to inform, gain input, and support decision making.
• Flexible working hours – Times will be required to be work in US EST time zone.

Nice to Have

• US and global regulatory affairs knowledge and experience.
• Experience working with cross-functional teams.
• Effective verbal and written communication skills both internally and externally.
• Experience with solving problems and concerns.
• Experience with project management and adherence to time schedules.
• Work well under pressure in a dynamic environment.
• Highly organized, detail-oriented, and efficient.
• Team player who seeks to help and learn from colleagues seeing the department success as their own
• Ability to manage projects to completion within and outside of the direct department and company.
• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
• Proactively seeks to develop and become well-versed within the regulatory landscape.
• RAPS Regulatory Affairs Certification (RAC).

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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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.

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.

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.