Regulatory Affairs Specialist Jobs

The job description is detailed below:

Position: Regulatory Affairs Specialist

Duration: 1+ year with possibility of extension

Location: Remote

Seeking candidates who have Regulatory experiences on Class I Medical Device, Consumer Products and Cosmetic Products. (MUST have at least 2 of the 3, all 3 are highly preferred). Cannot be Class 2 or Class 3 medical device, must be Class 1 or Class 1 exempt. Seeking candidates with Regulatory Project Management experience. Degree is required.

PRINCIPAL ACCOUNTABILITIES:

1. Participate and work independently on project teams developing/launching products by defining regulatory requirements and necessary regulatory deliverables to ensure compliance and successful achievement of business objectives.

2. Actively participate in the Innovation management process by providing targeted feedback on proposed product designs to ensure potential regulatory hurdles are identified at the earliest stages of a project and appropriate business decisions can be made.

3. Assess regulatory pathway for new product platforms and product modifications; Develop regulatory strategies, regulatory summaries, assessments and tactical plans to ensure compliance with FDA and Health Canada regulatory requirements.

4. Responsible for monitoring, interpreting, and implementing current and new regulatory requirements for U.S and Canada. Followed by appropriate preventive communication and training within the K-C business units.

5. Provide consultation and guidance relative to the resolution of regulatory and/or quality issues and non-compliances

6. Support product change management, complete product claims reviews, labeling/ingredient reviews to ensure regulatory compliance.

7. Establish and maintain an information network for purposes of monitoring domestic and international regulatory developments, followed by appropriate preventive communication and training within the K-C business units.

8. Collaborate with Research and Engineer, Marketing, and legal teams in the development of compliant medical device labeling and product claims.