We are currently seeking a Senior Regulatory Affairs Specialist to join our Joint Replacement Division based Hybrid in Mahwah, New Jersey.
Who we want
· Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
· Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
· Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
· Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
What you will do
As the Senior Re gulatory Affairs Specialist for Market Continuity , you will have an integral role in ensuring continued marketability of Stryker’s joint replacement implant devices. You will author regulatory submissions for both the U.S. and global regions, update and review technical files, and interact with regulatory agencies and notified bodies. The Senior Regulatory Affairs Specialist is the Regulatory SME on cross-functional teams and a key point of contact for internal partners. This is a highly visible position with exposure and interaction with various functions within the JRI division.
Participate in product sustaining teams as the Regulatory SME to ensure that Stryker continues to satisfy US, EU, and global regulatory requirements
Act as the Point of Contact for responsible products/technical files
Author and submit electronic regulatory submissions for the FDA and Notified Body
Prepare EU design dossiers/technical files and other related product documentation
Work with the RA team, Stryker Global Technology Center, and cross-functional partners on base business support such as annual file updates, NC/CAPA, and audits
Assist in developing regulatory strategy, approval pathways, and compliance activities
Negotiate with regulatory authorities and notified bodies to ensure continued compliance and efficiency of reviews
Track the status of applications under regulatory review, participate in interactive reviews, and provide updates to the regulatory and project teams
Provide input to projects leads to help develop timelines, perform global regulatory impact assessments, and complete change tasks
Support international submissions and international regulatory notifications
Perform regulatory reviews for technical documents such as clinical documents, post-market surveillance reports, and NC/CAPA
Maintain current product registrations and assist in processing registration changes when required
Assist with the creation of regulatory procedures, work instructions, and updates to technical and QMS procedures.
What you need
Required
Bachelor's Degree in Engineering, Science, or related degree
Minimum 2 years of work experience in medical device regulatory affairs
Time management skills, writing, coordination, and execution of basic regulatory items
Preferred
Master's Degree in Regulatory Affairs or other advanced degree in related area
Knowledge of FDA and international medical device regulations and standards (e.g. EU MDR) preferred
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