Work Flexibility: Remote or Hybrid or Onsite

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 Divisional Process Owner 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 0-2 years of experience in a regulated manufacturing environment is required; preferably in a Regulatory or Quality role.
• Knowledgeable in post-market regulatory activities preferred.
• Previous experience with adverse event reporting is preferred. 
• Experience with Post-Market MDR/MIR reporting is preferred.
• Knowledge of US and International Medical Device Regulations and Standards including but not limited to FDA: CFR 21 Part 803 (MDR), and CFR 21 Part 820 (QSR), ISO 13485 (International Organization for Standardization), etc. preferred.
• 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.
• Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines.
• Knowledge of manufacturing processes and demonstrated ability to advocate product excellence and quality.
• Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
• Experience interacting directly with FDA and Global Regulatory Bodies.
• 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.
• Knowledge of applicable and international regulations and standards preferred.
• Ability to understand and explain regulatory compliance issues.

$87,600.00 - $136,200.00 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.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.