Job Description

Who we wan

· 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

• BS in Engineering, Science, or related degree required

• Minimum of 2 years of experience in medical device regulatory affairs required

• Time management skills, writing, coordination, and execution of basic regulatory items

Preferred

• RAC certificate and/or Advanced Degree (Masters in Regulatory Affairs) preferred

• Knowledge of FDA and international medical device regulations and standards (e.g. EU MDR) preferred

Job Tags

Similar Jobs