Regulatory Affairs Specialist Job Overview
This is a 12-month contract with full benefits. The role involves assessing regulatory intelligence to support the development of local, regional, and global regulatory strategies.
1. Assess regulatory environment and provide internal advice throughout the product lifecycle.
2. Anticipate regulatory obstacles and emerging issues, developing solutions.
3. Identify requirements and potential obstacles for market access distribution.
The ideal candidate will have a BS in Engineering, Science, or related degree; or MS in Regulatory Science, with typically a minimum of 4 years' experience.
Responsibilities:
* Participate in advocacy activities of a technical and/or tactical nature.
* Evaluate proposed products for regulatory classification and jurisdiction.
* Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
Requirements:
* Provides regulatory information and guidance for product development and planning throughout the product lifecycle.
* Negotiates with regulatory authorities throughout the product lifecycle.
* Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
Benefits:
* Full Stryker benefits.
* Opportunity to work with cross-functional teams for interactions with regulatory authorities.