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Senior Regulatory Compliance Specialist - Mahwah, United States - Stryker
Description
Work Flexibility:
Hybrid
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 atWe are currently seeking a
Senior Specialist, Regulatory Compliance
to join our Joint Replacement Division based hybrid in Mahwah, New Jersey.
Who we want
People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
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 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
2+ 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 levels
Travel Percentage:
None
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.
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