Regulatory Affairs Administrator, Belgium - S
- Employer
- ClinChoice
- Location
- Belgium
- Salary
- Competitive
- Start date
- 6 Sep 2021
- Closing date
- 4 Oct 2021
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Location: Flemish Brabant, Belgium
Schedule: Full Time, permanent
TalentSource Life Sciences, the CROMSOURCE flexible resourcing department, is currently working with one of our partner sponsor's to hire a Regulatory Affairs Administrator to join their team as their permanent employee. This client is a dynamic and international company specialized in Medical Device.
Main Job Tasks and Responsibilities:
Legislation/standards
- Basic knowledge/understanding of relevant legislation/standards
- Prepare labels and IFU for the company products
- Review product labeling and IFU for products from other manufacturers
- Coordinate translations for multi-lingual labeling and IFU (including additional labeling activities in warehouse)
- Support review promotional material
- Assist business/sales organization in preparing RA related information
Product approvals
- Within EU, support CE marking (technical file, technical documentation) and notifications
- Worldwide: support registrations (registration files) (including impact of product change notifications)
- Item code creation in the company system by adjusting master data based on supplier input
- Complete and maintain regulatory databases
- Maintain the company system to prevent unauthorized sales (listing)
Communication
- Notified Bodies, Competent Authorities, RA partners (internal and external), pharmaceutical industry, consultants, other company associates (business, sales, engineering, quality, vigilance, IT, …)
- Possibility for ad hoc role as coordinator in document management system
Education and Experience:
- Bachelor (scientific background for example: chemistry, biochemistry, biotechnology, laboratory science, medical management, biomedical sciences, …)
- Or equivalent by experience
- Junior profile
Specific Role Requirements and Skills:
- Communication and organizational skills
- Accurate, eye for details
- Self-disciplined, independent worker, taking initiative
- Proficient in multitasking
- Easy learner
- Team player
- Ownership
- Fluent in English, other languages are a plus
The Benefits of Working for our Client
- Mealvouchers (7 Euro)
- Group and hospitalization insurances
The Application Process:
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs please contact careers@cromsource.com for more information.
Who are CROMSOURCE:
CROMSOURCE is an independent, international Contract Research Organisation (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe. Our international headquarters located in Verona, Italy and Waltham, USA and with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland and the United Kingdom.
By joining our client teams, you can be part of making a difference in the lives of people and experience a fulfilling and rewarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.
Keywords: Regulatory Affairs Administrator, Regulatory Affairs, Regulatory
Skills: Regulatory Affairs Administrator, Labelling, Medical Devices, Regulatory, Regulatory Operations Location: Belgium Share:
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Company
ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.
We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.
- Website
- https://clinchoice.com/
- Telephone
- +44 1628 566121
- Location
-
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom
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