Regulatory Compliance Officer

Role: Regulatory Compliance Officer

Contract: Via Randstad Company

As a Regulatory Compliance Officer in our IGTS business, you will support Regulatory and norm compliance activities. You will play a pivotal role in shaping the future of innovative medical devices by ensuring they meet the highest standards of safety and regulatory compliance.

Key responsibilities:

• Define applicable standards and regulations for products under development, such as IEC 60601-1 series, IEC 62304, IEC 62366, and EU MDR.

• Develop the Standards and Compliance plan, outlining how the required standards and regulations will be demonstrated as evidence of compliance.

• Create project deliverables related to Norm Compliance responsibilities.

• Ensure the implementation and verification of all specified legal requirements by reviewing related project deliverables.

• Support designers and testers with the interpretation and testing of standards and regulations concerning the technical design of IGT products.

• Arrange and complete all evidence required for gaining product certification by independent certifying agencies.

• Provide the Regulatory Affairs department with technical support for the preparation of submissions to regulatory bodies and countries, in line with IGT's planning.

Ideal Experience and Education for a Regulatory Compliance Officer:

• Bachelor’s or Master’s Degree in Engineering, Biomedical Engineering, Regulatory Affairs, or a related field with over 6 years of experience in regulatory compliance or quality assurance within the medical device industry.

• Strong knowledge and experience with medical device standards and regulations, including IEC 60601-1 series, IEC 62304, IEC 62366, and EU MDR.

• Demonstrated experience in developing and managing standards and compliance plans, creating project deliverables, and ensuring project milestones are met.

• Experience in supporting design and testing teams with interpreting and applying standards and regulations to technical designs.

• Experience providing technical support for regulatory submissions to bodies such as the FDA, EU regulatory authorities, and other relevant agencies.

Apply now to join our team! You can reach out to me in case of any questions or you can email me at Pallavi.mahadik_1@philips.com.