Senior Regulatory Affairs Specialist - Spine

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.

Senior Regulatory Affairs Specialist

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

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.

Job Responsibilities

• Process SME to ensure appropriate coordination and advise on consistent interpretation of required data attributes
• Keeps abreast of regulatory procedures and changes.
• Provide requested regulatory data and documents to support tenders
• Lead in development/maintenance of regulatory files, data, records, and reporting systems of systematic retrieval of information.
• Prepare, review, file, and support premarket documents for global registrations for assigned projects.
• Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.
• Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections.
• Compiles all materials required in submissions, license renewal and annual registrations
• Recommends changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance
• Monitors and improves tracking/control systems
• May direct interaction with regulatory agencies on defined matters.
• Develop Regulatory Strategies for new or modified products for assigned projects.
• Monitor and provide information pertaining to impact of changes in the regulatory environment.
• Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.
• Document, consolidate, and maintain oral and written communication with health authorities
• Prepare internal documents for modifications to devices, when appropriate.
• Author and/or review regulatory procedures and update as necessary.
• Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.

Minimum Qualifications

• Bachelor’s degree in Medical, Mechanical, Electric Life Science or other healthcare related majors
• 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.
• Ability to quickly establish credibility with all levels of customer base
• Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues to inform, gain input, and support decision making

Nice to Haves

• 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.

Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare further, together.
 

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. 

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.
 

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 90,000+ 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