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.

A Day in the Life

The Regulatory Affairs Specialist will be responsible for delivering and managing assigned projects collaborating with cross-functional stakeholders to achieve targeted outcomes. Focus is on executing and overseeing Southeast Asia (SEA) projectsincluding product changes such as RAN/RACfrom planning through implementation. All activities are carried out in compliance with relevant policies and standards leveraging specialized expertise and technical knowledge.

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

• Provide regulatory support for product registration submissions across Subcon territories (Sri Lanka Bangladesh Nepal Bhutan and Maldives) to ensure timely approvals.

• Coordinate with Global Regulatory Affairs (RA) and/or Center-led Teams (CLT) to obtain review and distribute technical documentation to local distributors

• Assess regulatory impact of product notifications and changes. Support related activities within SEA.

• Recommend strategies to achieve the earliest possible regulatory approvals and compliance for product changes.

• Monitor and enhance tracking and control systems to ensure regulatory efficiency.

• Stay up to date with evolving regulatory procedures standards and requirements.

• Collaborate with global RA teams and project stakeholders on defined regulatory matters.

• Establish and maintain quality assurance processes including drafting and updating SOPs work instructions and records.

• Ensure alignment with Regulatory Affairs KPIs and performance targets.

• Perform other duties as assigned to support regulatory and quality objectives.

Required Knowledge and Experience:

• Requires Bachelors Degree

• Minimum of 2 years Regulatory Affairs experience

• Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.

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.

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.

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 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