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 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
• Author product field action assessments and present summary of assessment to upper leadership and corporate teams.
• Work in a cross-functional teams to support writing reports, data summaries from raw data, and document strategies
• Work cross-functionally on known and emerging issues to make quality improvements
• Manage/hold meetings with intra/inter departmental groups
• Independently manage recall(s)
• Review and analyze data for trending purposes
• Utilize sound independent judgment to analyze areas for improvement and act on them
• Own corrective and/or preventive actions
• Work from verbal and/or written instructions
• Knowledge of applicable international regulations and standards and willingness to train others in quality assurance/GMP-related topics
• Develop and maintain positive relationships with regulatory agencies through professional oral and written communications
• Communicate directly with customers and regulatory agencies regarding reported complaints and resolutions
• Participate in Internal and External Audits
• May serve as …