SENIOR REGULATORY AFFAIRS SPECIALIST- INTERNATIONAL

Join 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). This job opening has a strong preference for candidates to be located on-site in CA, but a remote work option within the U.S. may be considered.

A Day In The Life

• 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 and Canada).
• Provide support to the Geography RA who interact with regulatory authorities to assure timely new product introductions 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 the company informed of regulatory requirements in international markets.
• Provide regulatory review of labeling, design changes, and specification changes as it relates to specific geographies.
• 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.
• Monitors and improves tracking/control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.

• Recommends strategies for the earliest possible approvals of clinical trials applications.

• Other duties as assigned or required.

Must Have: Minimum Requirements

• Bachelor's degree is 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.

• US, EU and/or international medical device regulatory submission/approval experience.
• Knowledge of EMEA, Health Canada, or other international 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 Skill s .

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)