Specialist - Regulatory Affairs - Healthcare

Regulatory Affairs Specialist

- 7 + years of work experience in Regularity Affairs and Product Certifications

- Mandatory Experience - Product certifications (Safety or EMC)

- Should be able to work as an independent contributor with minimal supervision and shall mentor team as required.

- Responsible for the coordination and implementation of regulatory strategy and compliance programs through the review, consultation, training, and support of each discipline (Engineering, Operations, Quality, Sales, Sourcing, etc.) to fulfill their business goals in a compliant manner.

KRA :

- Responsible for the coordination and implementation of regulatory strategy and compliance programs through the review, consultation, training, and support of each discipline (Engineering, Operations, Quality, Sales, Sourcing, etc.) to fulfill their business goals in a compliant manner.

- Responsible for interacting with a Regulatory Affairs network of people and resources in the business unit and provide general regulatory support in the regions and time zones where BU facilities operate, also, provide additional review and consultation for regulatory needs from centers of compliance excellence.

- Responsible for providing regulatory assistance in executing New and Existing Product Development projects (medium complexity level), monitor and manage timelines that are in RA's control, and provide a regular update to project stakeholders.

- Liaise between the respective disciplines and 3rd Party regulatory agencies (UL, CSA, TUV, Notified Bodies, FDA, ISO registrars, etc.) and ensures this interaction follows the established best practice model for the division.

- Responsible for execution of Class II (and above) medical device product registrations in various countries/geographies by working with the cross-functional teams (Engineering, Operations, Quality, Sales & Registration Agents )