We anticipate the application window for this opening will close on - 3 Dec 2024

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

The Regulatory Affairs Specialist provides global pre- and post-market support for coronary and renal denervation medical devices; is responsible for activities that lead to and maintain regulatory approval/clearance of these devices; and assesses the global regulatory implications of changes to these devices.

The Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for class III and/or class IIb products. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. 

Duties and Responsibilities:

• Collaborate with Operating Unit Regulatory Affairs Specialists and international regulatory colleagues to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to address questions from regulatory agencies.
• Provide support to currently marketed products as necessary. This includes reviewing labeling, product or process changes as well as supportive documentation for changes requiring regulatory agency review. Prepare submissions and reports for FDA or provide support and documentation for global submissions.
• Maintain proficiency in worldwide regulatory requirements. Obtain and distribute updated information regarding worldwide laws, guidelines, and standards. 
• Establish and maintain good relationships within the RA department, cross functional teams and assist in developing and maintaining positive relationships with device reviewers through oral and written communications.
• Support regulatory compliance activities, including internal or external audits, post-market surveillance activities, etc. as needed.
• Support product development programs as an extended core team member.
• Assist in negotiations with the FDA or other regulatory agencies for assigned projects.
• Other tasks, as assigned.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

• Bachelor’s degree required.
• Minimum of 2 years of experience in regulatory affairs in the medical device industry.
• Or advanced degree with a minimum of 0 years of experience in regulatory affairs in the medical device industry. 

Nice to Have (Preferred Qualifications):

• Effective and respectful team member who is detail oriented and capable of functioning on a global team.
• Experience working in a regulated, biotechnology environment with Class II/III medical devices and history of successful device submissions. interactions with regulatory agencies (e.g., FDA), and working with cross-functional project teams.
• Effective interpersonal, organizational and time management skills with experience in supporting multiple concurrent projects.
• Effective negotiation and written/oral communication skills with experience leading team meetings and working independently.
• Experience with FDA requirements, guidance documents, Medical Device Directive (MDD), Medical Device Regulation (MDR), and/or other global regulatory requirements and quality standards such as ISO 14971, ISO 13485 and IEC 60601.
• Experience with regulatory support of clinical trials.

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):$77,600.00 - $116,400.00This 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).

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 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.

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.