EU Regulatory Compliance Specialist — Drug/Device Trials
Medasource
A leading pharmaceutical firm is seeking a Regulatory Compliance Specialist to support a Quality Management System initiative focused on drug/device combination products. The role involves ensuring compliance with EU clinical trial regulations and streamlining internal processes. Ideal candidates will have strong experience in regulatory compliance and a proven track record in a pharmaceutical setting. This is a full-time, remote position with a preference for East Coast candidates. #J-18808-Ljbffr
- ...is an innovative medical device company focused on vascular... ...Role Description: dThe Regulatory Affairs (RA) Specialist is responsible for... ...regulatory submissions and compliance activities to ensure medical... ...submissions (e.g., FDA 510(k), EU MDR Technical...SuggestedInternshipWork at officeWorldwide
- ...Job Title: Regulatory Affairs Specialist II OnSite @Chaska location Mon... ...Regulatory experience in Medical Device Industry i.e Post Market... ...regulations, devises strategies for compliance, and liaison with... ...KNOWLEDGE, GLOBAL REGISTRATIONS (EU, CANADA, BRAZIL, LATIN...SuggestedContract workWork experience placementFlexible hours
- ...recognize their merit.Job Function: Regulatory Affairs GroupJob Sub... ...a Senior Regulatory Affairs Specialist to support our Instrumentation... ...experience within Medical Device is required (3+ years with Advanced... ...Management, Regulatory Compliance, Regulatory Development,...SuggestedFull timeLocal areaImmediate startRemote work
$30 - $36 per hour
...Job Description Job Title: Regulatory Affairs Associate I Position... ...Associate I to support regulatory compliance activities for products... ...certification in Cosmetic or Drug Regulatory Affairs preferred... ..., India, Netherlands, and the EU. IntelliPro, a global leader...SuggestedContract workWork experience placement- ...Description Job Title: USA_Regulatory Associate - Level 3 Location... ...projects, provide guidance on OTC drug regulatory pathways (... ...Support end-to-end regulatory compliance of products in remit. • Apply... ...framework for OTC drugs and devices, ensuring compliance standards...SuggestedHourly payContract workLocal area
- ...value and cost-effective generic drugs in the United States. Our... ...About the Role The Regulatory Affairs Senior Associate is responsible... ...and labeling supplements in compliance with FDA requirements.... ...transdermal systems, injectables, drug-device combinations). Create and...
$137k - $235.75k
...recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function... ...product types (pharma, devices, combo products).Intellectual... ...understanding of clinical drug development, working with US... ...Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making...Full timeLocal areaImmediate startFlexible hours- ...submission documentation according to eCTD requirements for New Drug Application (NDA) Prior Approval Supplements (Client), Changes... ...both internal and external cross-functional project teams.• The Regulatory CMC Technical Associate may be called upon to author technical...Work at officeLocal areaImmediate start
- ...Role Overview The Associate Manager, Regulatory Affairs supports the planning,... ...maintenance of regulatory filings to ensure compliance with applicable health authority requirements... ...products, including inhalation and/or drug-device combination products. The Assistant...Full timeWork at officeLocal areaMonday to FridayNight shift
$92.5k - $131.7k
...Have the Power to Win.Job SummaryChurch & Dwight is seeking a Regulatory Senior Specialist to join our team. This role is responsible for managing... ...processes and projects leading to the commercialization of OTC drug and cosmetic products across multiple business units.About...Full timeWork at officeRemote work- ...Clinical Research Revenue Cycle Coordinator to ensure accurate and compliant billing for clinical trials. The role collaborates with revenue cycle teams and the compliance department to support patient care billing and trial invoicing. The ideal candidate has a Bachelor...
- ...DESCRIPTION POSITION SUMMARY As a Compliance Analyst and a member of the MedPro Compliance... ...) you will leverage your compliance and regulatory expertise to provide education and solutions... ...our expanding Pharmaceutical, Medical Device, Hospital, Pharmacy, Wholesale...Work at office
$117k - $120k
AMNEAL PHARMACEUTICALS Regulatory Affairs Specialist With minimal supervision assists with the preparation of high-quality regulatory submissions to the Food and Drug Administration (FDA) as required, within company timelines and in accordance with regulatory guidelines...For contractorsLocal area- ...Foods offers delicious snacks, frozen meals, ice creams and other specialties. Position summary The FSVP/Regulatory Compliance Specialist supports and maintains the company’s Foreign Supplier Verification Program (FSVP) and import compliance activities for...Flexible hours
$70k - $75k
Regulatory Compliance Specialist Base pay range: $70,000.00/yr - $75,000.00/yr The Regulatory Compliance specialist, in this highly detail-oriented role, is responsible for coordinating the workflow of domestic and international product labeling projects, maintaining...Full timeWork at officeImmediate start- ...Job Responsibilities: Utilize the Regulatory Information Management System (RIMS) to manage... ...controls to support organizational compliance. Collaborate and provide cross-functional... ...department requirements such as device establishment registrations, device listings...
- ...160 countries and regions. Position Summary The Regulatory Affairs Specialist supports global regulatory submissions, registrations, and... ...& Experience · Working knowledge of medical device regulatory requirements and FDA regulatory processes. ·...Work at officeFlexible hours2 days per week
- ...under the guidance of the Global Quality Computer Compliance team.Job duties will include:Reviewing and... ...of US FDA regulations, ISO standards, MHRA and EU regulations (including Annex 11), and ICH guidelines and Drug Development Life Cycle process. Extensive experience...Work experience placementWork at office
$27 - $29 per hour
...Job Description Job Description Regulatory Affairs Specialist (Food/Flavors) Location: Piscataway, NJ Pay: $27-29/hr Duration: Temporary... ...Prior experience in Regulatory Affairs , Regulatory Compliance, or a related field Strong experience with extensive...Full timeTemporary workLocal areaMonday to Friday- ...other individuals involved in regulated activities to ensure compliance with applicable regulatory obligations. Act as the main point of contact for... ...with regulators and supervisory bodies, ideally within the EU, and managing regulatory relationships effectively. Strong...
- Balazs in Fairfield, NJ, is seeking a Regulatory Specialist to drive compliance excellence for their Cosmetics and Nutrition divisions. This role is vital in managing global documentation requests and adhering to FDA guidelines. The ideal candidate will have a strong foundation...
- ...Job Description Job Description EHS, QMS & Regulatory Specialist Specialty Chemical Manufacturer | Carlstadt, NJ | Full-Time, On-Site... ...both systems Environmental, Health & Safety Own EHS compliance across federal, New Jersey, and local requirements (OSHA, HazCom...Full timeLocal area
- Overview R10094604 Regulatory Specialist (Open) Location: Fairfield, NJ (Seppic) - Sales - North America zone. An Air Liquide Healthcare company... ...at Seppic Inc. acts as a crucial link between scientific compliance and global market access, safeguarding portfolios while...Worldwide
- The Regulatory Specialist is an on-site role responsible for ensuring that products, ingredients, formulations, and labeling comply with all... ...documentation, product registration, product SDS, and supports formula compliance checks. The Regulatory Specialist works cross-functionally...Work at office
$36 - $39 per hour
...COMHAR strictly follows a zero-tolerance policy for abuse. COMHAR is proud to be an Equal Opportunity Employer. We maintain a drug-free workplace. COMHAR, Inc. is a not-for-profit community-based health and human service organization founded in 1975. We do not discriminate...Hourly payDaily paidFull timeLocal area- ...Basic Purpose of the Job)The Quality and Regulatory Affairs Specialist - PACE supports the Quality and... ...Manager in implementing and maintaining compliance and quality improvement activities... ...following benefits:Medical PlanPrescription drug coverage & In-House Employee...Full timeTemporary workPart timeWork at office
- .../financial flexibility by offering contingent labor as a variable cost.Job DescriptionThis individual will be part of the Global Regulatory Affairs team and assists with planning, writing, compilation, and editing of periodic regulatory reports (i.e. DSURs, orphan annual...Work at officeImmediate start
- Job Description The Specialist, International Labeling Support will partner cross functionally... ...ensure all the Labeling and Artworks regulatory operational activities in scope of ILS... ...(including labelling & artwork), CMC, compliance management or quality, working with...Local areaFlexible hours
$86.7k - $170.9k
Position Summary Consultant - Regulatory & Compliance - Enterprise Operations & Risk Our Deloitte Regulatory, Risk & Forensic team helps client leaders translate multifaceted risk and an evolving regulatory environment into defensible actions that strengthen, protect...Local areaVisa sponsorship$78k - $156k
...products in diagnostics, medical devices, nutritionals and branded... ...a Senior Customs & Trade Compliance Analyst. You will provide subject... ..., FDA, USDA, and other US regulatory agency requirements.What You... ...Broker or Certified Customs Specialist preferred.Learn more about...Shift work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to EU Regulatory Compliance Specialist — Drug/Device Trials. Be the first to apply!
- regulatory analyst New Jersey
- risk and compliance analyst New Jersey
- regulatory affairs specialist New Jersey
- compliance analyst New Jersey
- aml compliance analyst New Jersey
- medicare compliance specialist New Jersey
- regulatory officer New Jersey
- compliance coordinator New Jersey
- coding compliance specialist New Jersey
- compliance officer New Jersey



