- 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.
- 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
-
BMW Woodcliff Lake, United StatesAs an independent group of companies, the BMW Group has a commitment to creativity and breakthrough ideas that goes well beyond the racetrack. In order to continuously create ultimate driving machines, we drive our growth and design excellence by staffing our teams with individua ...
-
Compliance Specialist
1 week ago
ADAPT Community Network New York, United States**Why Join ADAPT?** · It's more than a job; it's a calling. It's where passion meets purpose. ADAPT Community Network, formerly United Cerebral Palsy (UCP) of NYC provides a multitude of services to people with developmental disabilities. At ADAPT, we are 3,000 strong, and it tak ...
-
Compliance Specialist
1 week ago
New York City Housing Development Corporation (HDC) New York, United States· **Position Summary**: · The Compliance Specialist reports to the Assistant Vice President of Compliance and is responsible for monitoring and evaluating compliance within HDC's Low Income Housing Tax Credit (LIHTC), Tax Exempt Bond (TEB), and Taxable Bond (TB) properties. · ** ...
-
Compliance Specialist
1 week ago
WB Residential Communities, Inc. Chappaqua, United States**Compliance Specialist** · **Duties**: · - Update waiting list and ensure accurate notes. · - Understands income limit requirements & rent charges with applicant households. · - Conducts applicant background checks & hold applicant interviews to prepare initial Tenant Certificat ...
-
Specialist in Compliance
2 weeks ago
NebulaWorks Clifton, United StatesA publicly listed German reinsurance company specializing in various areas of property and casualty and life reinsurance is seeking a Compliance Management System Specialist (m/f/d). You will benefit from a pleasant working environment and numerous development opportunities. · Yo ...
-
Environmental Compliance Specialist
4 days ago
EmployVision Bergen County, NJ, United States**Environmental Specialist** · **Bergen County, NJ** · **Job Description-** · This role is responsible for ensuring compliance and coordinating efforts related to TSCA (PMN, LVE preparation/NOC submittals) and DSL compliance. Also ensure that additional regulatory practices are i ...
-
Document Compliance Specialist
4 days ago
Independent Chemical Corporation Paterson, United StatesRole & Responsibilities: · 1. Document Compliance Specialist is required to ensure that · product support and compliance documentation is current and complete in order · to facilitate timely resolution of internal and external customer requests and · concerns regarding chemical p ...
-
Medicare Compliance Specialist
6 days ago
MetroPlusHealth New York, United States**Empower. Unite. Care.**: · **MetroPlusHealth** is committed to empowering New Yorkers by uniting communities through care. We believe that Health care is a right, not a privilege. If you have compassion and a collaborative spirit, work with us. You can come to work being proud ...
-
Contract and Compliance Specialist
1 week ago
Upwardly Global New York, United States**Title: Contract and Compliance Specialist** · **Department: Finance** · **Reports to: Director of Budget and Grants Compliance** · **Location: New York, San Francisco, Chicago or DC** · **FLSA Status: Exempt** · **About the Organization** · Over the years, Upwardly Global has s ...
-
HR Compliance Specialist
2 weeks ago
The College Board New York, United StatesHR Compliance Specialist (temp) · - College Board - Global Strategy & Talent- work location · - is regularly commutable for you. · Type: This is a temp position expected to last 3-6 months from the start date · - Anticipated Start date: May 7 · - About the Team · - The Talent tea ...
-
Academic and Compliance Specialist
2 weeks ago
Eastern International College Jersey City, United StatesThe Academic and Compliance Specialist (ACS) leads and coordinates the development of new academic programs and ensures regulatory compliance with State and accreditation standards and procedures. The ACS also coordinates, formulates, and conducts faculty professional development ...
-
Compliance and Audit Specialist
6 days ago
DocGo New York, United StatesTITLE: COMPLIANCE & AUDIT SPECIALIST · - SALARY: $72,500-$82,000 · - LOCATION: DocGo HQ, 35 W 35th St. New York, NY 10001 · - EMPLOYMENT TYPE: Full Time, On-Site · - BENEFITS: Medical, Dental, and Vision (with company contribution), Paid Time Off, 401k · ABOUT DOCGO: · - DocGo is ...
-
Environmental Compliance Specialist
2 weeks ago
FMC Corporation Newark, United StatesFMC Corporation is a global agricultural sciences company dedicated to helping growers produce food, feed, fiber and fuel for an expanding world population while adapting to a changing environment. FMC's innovative crop protection solutions - including biologicals, crop nutrition ...
-
Saint Dominic's Family Services Blauvelt, United StatesThe Compliance Specialist, Developmental Disabilities is responsible for the tracking and collecting all developmental disabilities data/reports related to accountability services and will be responsible for supporting incident management practices across all OPWDD programs. · ** ...
-
Lead HR Compliance Specialist
2 weeks ago
Starbucks New York, United States**Now Brewing - Lead HR Compliance Specialist -#tobeapartner** · **From the beginning, Starbucks set out to be a different kind of company**. One that not only celebrated coffee and its rich tradition but also brought a feeling of connection. We are known for developing and suppo ...
-
Wealth Management Compliance Specialist
2 weeks ago
EF Hutton New York, United States**The Company** · EF Hutton is a fast-paced, high-growth, global investment bank founded by experienced investment professionals that have collectively financed over $250 billion for public and private companies alike. EF Hutton offers strategic advice and financing solutions to ...
-
Staff Regulatory Compliance Specialist
3 days ago
Stryker Mahwah, United StatesWork 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 Spin ...
-
Senior Regulatory Compliance Specialist
3 days ago
Stryker Mahwah, United StatesWork 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 Spin ...
-
Quality Assurance Compliance Specialist
4 days ago
Json South Hackensack, United States**Summary**: This position will be responsible for working with QC and other departments to coordinate acceptable outcomes on distributor quality complaints. Effectively execute company processes while researching claims and project situations, in reaching project resolution. Ass ...
-
Environment of Care Compliance Specialist
3 days ago
NewYork-Presbyterian Hospital Manhattan, United States**Environment of Care Compliance Specialist - Facilities** · This position is responsible for monitoring and tracking the organization's compliance with, and also providing regulatory expertise and guidance as it relates to The Joint Commission's Environment of Care (EOC), Life S ...
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 at
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.
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.
