We are currently seeking a Senior Staff Regulatory Compliance Specialist 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 Staff Regulatory Compliance Specialist, 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 taken
Author and update divisional SOPs, recommend timely changes to ensure regulatory compliance, and support process improvement initiatives to maximize efficiencies
Manage 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 required
7+ years of work experience as a Regulatory or Quality professional in a regulated manufacturing environment, preferably Medical Devices
Preferred experience in Health Hazard Evaluations, MDR/MDV reporting and product recalls
In-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 Quality
Proficient with Microsoft Office and ability to learn Corporate systems
Understanding of ERP systems (commercial holds, distribution reports)
Knowledge of manufacturing processes and demonstrated ability to advocate product excellence and quality
Ability to interface with both technical and non-technical personnel at all organizational level
More Information
Application Details
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Organization Details
Stryker
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