Senior Regulatory Affairs Compliance Specialist (Remote)

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com

Who we want

• Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams. 
• 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. 

We are currently seeking a Senior Regulatory Compliance Specialist to join our Endoscopy Division to be based in San Jose, CA, Flower Mound, TX, Denver, CO or remote.

What you will do

As the Regulatory Compliance Specialist, you will be responsible for planning, coordination, and execution of post market regulatory compliance activities, such as field actions assessments, commercial holds, and recalls, in addition to leading continuous improvement initiatives. You also may work through supporting post-market regulatory reporting activities, including but not limited to coordinating communications between Stryker and global regulatory agencies, adverse event reporting and complaint handling.

• Lead the division/BU on recommendations for field actions and commercial holds
• Independently author concise product field action assessments and present summary of assessments to senior leadership and corporate teams
• Serve as front room subject matter expert during internal and external audits and inspections
• Lead cross-functional teams to support writing reports, data summaries from raw data, and document strategies
• Maintain up-to-date knowledge and understanding of applicable medical device regulatory requirements and standards, including but not limited to 21 CFR 820, 21 CFR 806, ISO13485, MDSAP, and EU MDR
• Proactively identify and implement creative solutions for process improvements and efficiencies
• Collaborate and effectively communicate with cross functional partners on emerging issues
• Independently launch and manage recall(s), including communications to regulatory agencies and customers
• Develop and maintain positive relationships with regulatory agencies through professional oral and written communications
• Author and revise procedures and work instructions to ensure compliance …