Senior Regulatory Affairs Specialist (Remote)

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 LifeJoin a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident —we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
Careers that Change Lives
The Senior Regulatory Affairs (RA) Specialist - International will plan and execute global regulatory activities necessary to obtain and maintain regulatory approvals within International markets. This position ensures compliance with required global regulations and Medtronic policies for Diabetes products and serves as a key team member and/or in a lead role on extended team(s).

Responsibilities may include the following and other duties may be assigned.

• Partner with Geography RA to plan, develop and execute global regulatory activities necessary to obtain and maintain regulatory approvals in International markets (such as, EMEA – Middle East and Africa, Rest of EMEA, and LATAM).
• Provide support to local In-country RA affiliates who interact with regulatory authorities to assure timely approvals and continued product access.
• Prepare submissions, interact more effectively with the regulatory agencies and negotiate submission issues as needed.
• Participate and represent OUS regulatory function in sustaining (Including MDR) and new product development projects to provide OUS regulatory requirements.
• Assist in keeping company informed of regulatory requirements in International markets.
• Supports Geography RA team to prepare International submissions and obtain product approval/clearance to include assistance with government queries and registration documentation requirements.
• Supports International product demand planning and release activities.
• Reviews Change Orders and assess regulatory impact of product changes on International regulatory strategy and submissions per standard procedures.
• Supports post market regulatory compliance activities for International product approvals.
• Develops and maintains regulatory affairs department procedures and process improvements.
• Provide mentorship, training and support to other members of the department.
• Other duties as assigned or required.

Must Have: Minimum Requirements

• Bachelor’s degree required with a minimum of 4 years of medical device regulatory affairs experience.
• OR an advanced degree with 2 years of medical device regulatory affairs experience.

Nice to Have

• US, EU and/or International medical device regulatory submission/approval experience.
• Knowledge Int’l regulations/requirements.
• Knowledge/experience with EU MDR implementation.
• Experience working in a cross-functional team setting.
• Strong Interpersonal and analytical skills.
• Strong communication skills.
• Attention to detail.
• Strong Technical Writing Skills.

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):$88,800.00 - $133,200.00

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).

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.

At Medtronic, most positions are posted on our career site for 3-7 days. 

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