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. - Direct or coordinate and prepare document packages for regulatory submissions across all areas of the company, internal audits, and inspections - Oversee or compile all materials required for submissions, license renewals, and annual registrations - Recommend changes to labeling, manufacturing, marketing, and clinical protocols to ensure regulatory compliance - Monitor and improve tracking and control systems - Stay current with regulatory procedures and changes - May lead interaction with regulatory agencies on defined matters **Qualifications** - Bachelor’s degree - One year of relevant experience in regulatory affairs or related areas - Fluent English level (Reading/Writing/Comprehension) - Strong organizational skills and effective time management skills - Document interpretation, queries and workflow skills. - Flexible with changing priorities and works well under pressure in a fast paced, dynamic environment - Knowledge in MS Office, Excel and proficient in software use. - Experience with SAP and GTS is advantageous - Experience with PLM use (Product Life Management tools e.g. Agile) - Ability to work in matrix structured organization. - Able to work in a Hybrid environment **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. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). **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 95,000+ 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.