Senior Regulatory Affairs Compliance Specialist (Remote)

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits.

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 with evolving regulatory standards and process improvement
• Own corrective and/or preventive actions
• May serve as Divisional Process Owner (DPO) for Product Field Actions (PFA) or Hold
  
  

What You Need

• A minimum of a bachelor’s degree (B.S. or B.A.) required, preferably in Science, Engineering or Regulatory.
• A minimum of 3-5 years of experience in a regulated manufacturing environment is required; preferably in a Regulatory or Quality role.
• Experience interacting directly with FDA and Global Regulatory Bodies, including audits and inspections is preferred.
• Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines.
• Knowledge in post-market regulatory activities preferred.
• Experience in Trackwise is preferred.
• Experience in SAP is preferred.
• Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
• Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development and Marketing and Quality.
• Demonstrated problem-solving and troubleshooting skills.
• Proficient with Microsoft Office and ability to learn corporate systems.
• Knowledge of manufacturing processes and demonstrated ability to advocate product excellence and quality.
• Analyze and resolve business and compliance issues using independent judgment.
• Communicate and network with personnel at all levels of the business to obtain relevant information.
• Ability to understand and explain regulatory compliance issues.
• Previous experience with adverse event reporting is preferred.
• Experience with Post-Market MDR/MIR reporting is preferred.
• $97,900.00 - 156,900.00 USD Annual salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits.  Actual minimum and maximum may vary based on location.  Individual pay is based on skills, experience, and other relevant factors.
  
  

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker 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 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.