Senior Regulatory Compliance Specialist (Hybrid)

Why RA/QA at Stryker?

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics 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

We are currently seeking a Senior Specialist, Regulatory Compliance to join our Joint Replacement Division based hybrid in Mahwah, New Jersey.

Who We Want

Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 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. Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What You Will Do

As Senior Specialist, Regulatory Compliance, you will support organizational decision on product field actions. You will perform recall activities including facilitating technical and medical assessments, completing product field action assessments, sending recall communications to the field, and gathering and submitting relevant documents to FDA.

Address requests for information from Competent Authorities. Manage the commercial hold process, including supporting scope assessment, running distributions reports, executing and tracking commercial holds. Assess links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy.Support management of high-level projects and initiatives, with responsibilities that include defining, managing and executing project charters and partnering with cross-functional groups to establish roles, responsibilities, and deliverables.Capable of clearly identifying, analyzing, and understanding potential risks and problems and work with management to and assure the appropriate actions are takenAuthor and update divisional SOPs, recommend timely changes to ensure regulatory compliance, and support process improvement initiatives to maximize efficienciesManage product field actions, including: Initiate, manage, and execute Health Hazard Evaluation, facilitate technical and medical assessments, develop recall communication plan with the sales and marketing organization and communicate potential actions to internal stakeholders.Communicate recalls to FDA within 10 days of decision. Gather, organize and submit all relevant recall documentation to FDA.Submit recall communication to FDA District office and receive approvals.Manage and oversee recall communications with FDA including any additional information FDA requests in classification letters or closure letters. Ensure reports to FDA / Competent Authorities including additional information requests are completed within required timelines.Manage commercial holds as applicable. Support scope and containment activities related to commercial holds. Draft commercial hold communication to internal stakeholders Implement commercial holds coordinating with stakeholders including marketing, sales, field organizations, OUS RA/QA. Oversee reporting of recall effectivity to corporate entities.Track metrics on process timeliness and effectiveness.

What You Need

Bachelor's Degree required2+ years of work experience as a Regulatory or Quality professional in a regulated manufacturing environment, preferably Medical DevicesPreferred experience in Health Hazard Evaluations, MDR/MDV reporting and product recallsIn-depth knowledge of FDA and international medical device regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.)Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development, Marketing and QualityProficient with Microsoft Office and ability to learn Corporate systemsUnderstanding of ERP systems (commercial holds, distribution reports)Knowledge of manufacturing processes and demonstrated ability to advocate product excellence and qualityAbility to interface with both technical and non-technical personnel at all organizational levels

About Stryker

Our benefits

12 paid holidays annually 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.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits

About Stryker

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 stryker.com.

Know someone at Stryker?

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Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.