Regulatory specialist Jobs in Grand Rapids, MI
Last updated: 23 hours ago
The Specialist will support the Regulatory Affairs department in implementing and administering activities that ensure regulatory compliance for the organization.
This role plays a key part in maint...Show moreLast updated: 2 days ago
Roche favorise la diversité, l’équité et l’inclusion, reflétant ainsi les communautés auxquelles nous nous adressons.Dans le domaine de la santé à l’échelle mondiale, la diversité est un ingrédient...Show moreLast updated: 23 hours ago
Founded in 1923 and headquartered in Grand Rapids, Michigan, Roskam Foods is a leading contract manufacturer that partners with world-renowned food brands, retailers, and food service providers to ...Show moreLast updated: 30+ days ago
Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere.
For 70 years, our team has driven meaningful innovations in kid...Show moreLast updated: 2 days ago
Pharmaceutical – RA Manager – Singapore – Full-time – Permanent].I am representing a prominent pharmaceutical company in their search for a new RA Manager.
This leading organization specializes in t...Show moreLast updated: 4 days ago
Offering $3000 Signing Bonus • • •.Culligan Water is seeking an individual with technical experience to provide installation, service and repair of Culligan water treatment products in the field.The f...Show moreLast updated: 3 days ago
SpendMend Pharmacy, is to focus on 340B compliance and optimization, so that hospitals and clinics can focus on their patients and to help covered entities improve their 340B program by sharing our...Show moreLast updated: 8 days ago
Assist the Head of Internal Audit in discharging its responsibilities by performing independent review to ensure : -.Soundness and adequacy of governance, risk management and internal control system...Show moreLast updated: 4 days ago
Duke-NUS Medical School (Duke-NUS) was established through a landmark collaboration between two world-class institutions.
Duke University and National University of Singapore, with the objective of...Show moreLast updated: 4 days ago
Fox Motors has a Sales Consultant opening in Grand Rapids, MI at Fox Subaru.You would contribute to our overall vision, “Working together moving people throughout life,” by developing and maintaini...Show moreLast updated: 2 days ago
A senior member of the compliance team, focusing on regulatory liaison duties and driving conduct and culture matters pertaining to the distribution channel.
Manage and track the company’s engagemen...Show moreLast updated: 23 hours ago
This job is responsible for leading large projects and initiatives related to the risk case management and intake activities of Highmark Health in support of a broad range of frameworks and oversig...Show moreLast updated: 30+ days ago
GigCX Marketplace is partnering with Teleperformance.TurboTax, to help millions of people file their taxes smarter each year.
A big part of our success comes from our customers’ positive experiences...Show moreLast updated: 1 day ago
Senior leader to advance BCBSA’s legislative and regulatory policy solutions and market positioning in Medicare, Medicaid, Duals, and Children's Health Insurance Program, impacting the tens of mill...Show moreLast updated: 30+ days ago
To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily.Reasonable accommodations may be made to enable individuals with disabilities to p...Show moreLast updated: 1 day ago
Contemporary Amperex Technology Kentucky (CATK) is the US battery manufacturing subsidiary of Contemporary Amperex Technology Co.
CATL is a global leader in research, development and manufacturing o...Show moreLast updated: 4 days ago
- Promoted
Senior Regulatory Affairs Specialist, APAC
Zoll Medical CorporationSingapore, Michigan, SingaporeFull-time
- Promoted
Regulatory Affairs Manager
F. Hoffmann-La Roche GruppeSingapore, Michigan, SingaporeFull-time
- Promoted
R&D Regulatory Manager
Roskam BakingGrand Rapids, MI, United StatesFull-time
- Promoted
Regulatory Affairs Manager
This is an IT support groupSingapore, Michigan, SingaporeFull-time
- Promoted
Legal / Senior Counsel - Commercial / Regulatory
Sdlegal AsiaSingapore, Michigan, Singapore Legal / Senior Counsel - Commercial / Regulatory.Regionally focused client with an excellent reputation as a leading figure in the Financial Services / Technology sector.
In this role, you will focus ...Show moreLast updated: 7 days ago
- Promoted
Regulatory Affairs Manager, Singapore and ASEAN
BARRINGTON JAMES LIMITED Singapore BranchSingapore, Michigan, SingaporeFull-time +1
- Promoted
Legal Counsel - Fintech Product and Regulatory Strategy
Booking Holdings, Inc.Singapore, Michigan, Singapore But our company is more than datasets, lines of code or A / B tests.We’re the thrill of the first night in a new place.The excitement of the next morning.
Through our products, partners and people, we...Show moreLast updated: 7 days ago
- Promoted
Service Specialist
Culligan Kaat's Water ConditioningGrand Rapids, MI, USFull-time
- Promoted
340B Specialist
SpendMend LLCGrand Rapids, MI, USFull-time
- Promoted
Senior Manager, Regulatory Audit
RHB Bank SingaporeSingapore, Michigan, SingaporeFull-time
- Promoted
Senior Executive (Standards Development Organisation, Centre of Regulatory
Duke-NUS Medical SchoolSingapore, Michigan, SingaporeFull-time
- Promoted
Product Specialist
Fox SubaruGrand Rapids, MI, United StatesFull-time
- Promoted
Regulatory Conduct and Culture, Director
Manulife FinancialSingapore, Michigan, SingaporeFull-time
Senior Regulatory Implementation & Assurance Analyst
Highmark HealthMI, Working at Home, Michigan$124,800.00 yearly
Full-time
- Promoted
Product Specialist
Teleperformance-Turbo TaxGrand Rapids, MI, United StatesFull-time
Executive Director, Legislative and Regulatory Policy
001_BCBSA Blue Cross and Blue Shield AssociationUS Michigan RemoteRemote
Full-time
- Promoted
Account Specialist
Vallen DistributionGrand Rapids, MI, United States Why Join our Team? At Vallen, we embrace what makes us unique.We thrive on the diversity of our associates and the different ways each of us contributes to Vallen's success.We pride ourselves on be...Show moreLast updated: 17 days ago
- Promoted
Behavioral Specialist
Grand Rapids Public School DistrictGrand Rapids, MI, United StatesFull-time
- Promoted
Procurement Specialist
Contemporary Amperex Technology Kentucky LLCMichigan, United States, United StatesFull-time
Senior Regulatory Affairs Specialist, APAC
Zoll Medical CorporationSingapore, Michigan, Singapore2 days ago
Job type
- Full-time
Job descriptionUniversity degree with 3 to 5 years of Regulatory Affairs experience, preferably within the healthcare medical devices industry. Possess a strong understanding of APAC medical regulations and demonstrate working knowledge of FDA medical device regulations, European Medical Device Regulations, and other global regulations. ISO 13485 knowledge is a plus. Strong organizational skills and results-oriented mindset. Ability to manage tasks under pressure while maintaining accuracy. Excellent written and verbal communication skills.
Job Summary
The Specialist will support the Regulatory Affairs department in implementing and administering activities that ensure regulatory compliance for the organization. This role plays a key part in maintaining the regulatory standards necessary for the smooth operation and success of our medical devices in global markets.
Essential Functions :
- Participate in product core teams to ensure compliance with both internal and external regulatory requirements.
- Develop, document, and implement regulatory strategy plans to align with product development goals.
- Prepare technical dossiers for submission to regulatory authorities in key target markets.
- Respond to inquiries from regulatory agencies with clear, accurate, and well-written communication.
- Assess the impact of change orders for compliance with APAC regulations and standards.
- Implement and maintain submission templates to streamline regulatory processes.
- Keep regulatory files organized and up to date.
- Ensure all product licenses are properly maintained and comply with regulatory requirements.
- Stay informed on the latest device regulations, guidance, and standards, and provide updates to the team as needed.
- Contribute to department improvements by making recommendations for enhancing submission accuracy and efficiency.
- Assist with device recall activities when required.
- Participate in internal audit activities as an auditor.
Required / Preferred Education and Experience :
About Us
At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.
At ZOLL, you won’t just have a job. You'll have a career—and a purpose. Join our team. It’s a great time to be a part of ZOLL!
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