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. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

This role is responsible for driving product registrations maintaining licenses and ensuring ongoing post-market regulatory compliance. The position serves as a critical bridge between local commercial teams and regional regulatory bodies to ensure timely patient access to life-saving medical devices.

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

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company internal audits and inspections.

• Leads or compiles all materials required in submissions license renewal and annual registrations.

• Recommends changes for labeling manufacturing marketing and clinical protocol for regulatory compliance.

• 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 earliest possible approvals of clinical trials applications.

Required Knowledge and Experience:

• Bachelors degree required (or equivalent qualification in line with regulatory standards); advanced degree preferred

• Minimum 4 years of relevant experience in regulatory affairs within the medical device or healthcare industry

• Working knowledge of regulatory requirements and submission processes

• Experience supporting product registrations renewals and compliance activities

• Strong organizational and documentation skills

• Ability to manage multiple projects and timelines effectively

• Excellent English communication skills with the ability to collaborate across teams

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 95000 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