About the Job
Summary
The Regulatory Specialist is responsible for the implementation and oversight of Gold Standard Diagnostics’ Regulatory System, to improve compliance and operational efficiencies.
Essential Duties & Responsibilities
- Preparation of regulatory documents or submissions for new products being developed and changes to current products
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
- Coordinate, prepare, or review regulatory submissions for domestic or international projects
- Interpret regulatory rules or rule changes and ensure that they are communicated through policies and procedures
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Determine the types of regulatory submissions or internal documentation that are required for proposed device changes or labeling changes
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance
- Prepare or coordinate the preparation of additional information or responses as requested by regulatory agencies
- Prepare or maintain technical files as necessary to obtain and sustain product approval
- Perform additional duties as assigned by supervisory or management personnel
Scope of Authority
Regulatory approval for DACF’s, reports and submissions
About the Company
Eurofins
Luxembourg, Luxembourg
5000 +
<div class="org-about-module__description"> <div id="ember58" class="ember-view organization-about-module__content-consistant-cards-description"><span class="lt-line-clamp__raw-line">Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is a global leader in food, environmental, pharmaceutical and cosmetic product testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. Since 1987, Eurofins has grown from one laboratory in Nantes, France to ca. 62,000 staff across a network of independent companies in 62 countries, operating over 900 laboratories. Performing over 450 million tests every year, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing. Ever since its IPO on the French stock exchange in 1997, Eurofins has been one of the fastest growing listed European companies.</span></div> </div> <div class="org-about-module__content-improvement"> <div class="org-about-module__content-box"> </div> </div>
Similar Jobs
Regulatory Affairs Manager
Regulatory Affairs Manager
- Freudenberg
- United States
- Remote
- Full time role
"Tailor-made emission-neutral energy systems for sustainable heavy-duty e-mobility."
19 days ago
QC Compliance Specialist
QC Compliance Specialist
- Eurofins
- Limerick, LK, IE
- In-person
- Full time role
Analytical testing services promoting safer, healthier, and more sustainable environments globally.
17 days ago
Quality Assurance & Compliance Officer - 15 Month FTC
Quality Assurance & Compliance Officer - 15 Month FTC
- Eurofins
- Guildford, England, GB
- In-person
- Full time role
Analytical testing services promoting safer, healthier, and more sustainable environments globally.
12 days ago