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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 or Remote.

What you will do

As the Regulatory Compliance Specialist, you will be responsible for supporting post-market regulatory reporting activities, including but not limited to coordinating communications between Stryker and global regulatory agencies, adverse event reporting, and ensuring product compliance. You will also be responsible for participating in and leading high-level cross-functional projects and initiatives from planning through close-out, including the development and maintenance of dashboards and metrics to monitor the project status. You will review and assess all incoming product complaints according to the regulatory requirements governing MDR and/or MIR Reporting to determine if the event meets reporting criteria. For reportable events, you will be expected to ensure reports are well-written and submitted to the applicable agency within the required timeframes. For events that do not meet reporting criteria, you will utilize data from risk table documentation and/or liaise with clinicians and subject matter experts to compose a comprehensive rationale for not reporting the event to Regulatory Agencies. Additionally, you will be responsible for addressing various inquiries from global Regulatory Agencies through direct communications and various regulatory audits. To ensure continuous process improvement and efficiency, you will also be expected to participate and/or lead various projects and initiatives with the team as well as our cross-functional partners.

Review and approve investigations of returned products and/or related reports.

Review reports of customer complaints and assess them for regulatory reporting.

Submit initial and follow-up reports to device related regulatory agencies as appropriate.

Interact with regulatory agencies on adverse event reporting and vigilance reports.

Review and approve non-conformances and planned deviations.

Review and analyze data for trending purposes.

May coordinate recalls and complete associated documentation.Recommend corrective and/or preventive actions to address non-conformities and deviations.

Work with engineering groups to ensure testing as required on product investigations is completed.

Interact with customers and sales force to solve reliability issues and/or complaint issues.

Work from verbal and/or written instructions.

Aid in developing statistical process controls and analyzing data.

Act independently to determine daily activities and project implementation.

Provide leadership, training and mentorship to team members.

Reviews and approves advertising and promotion to ensure regulatory compliance.

Assures post-market regulatory requirements are met (e.g., required reports, supplemental submissions, and other post-marketing commitments)

Participates in implementation of regulatory strategy and processes for handling recalls and communication to stakeholders (e.g., HCP, patient, distributor, and health authorities)

Reports product safety issues to regulatory authorities as required, to comply with local, regional, and global regulations.

Provides regulatory input and appropriate follow-up for inspections and audits.

Participate in internal and external audits.

Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.

Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.

Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.

Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)

Assists in the development of regulatory strategy and updates strategy based upon regulatory changes.

Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.

Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.

Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes.

Negotiates with regulatory authorities throughout the product lifecycle.

Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation.

Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.

Assists other departments in the development of SOPs to ensure regulatory compliance.

Serve as Divisional Process Owner for Complaint Handling, Adverse Event Reporting.

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.

Work in a cross-functional teams to support writing reports, data summaries from raw data, and document strategies.

Previous experience with adverse event reporting is preferred.

Experience with Post-Market MDR/MIR reporting is preferred.

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 ADD 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.

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.