Regulatory Affairs Administrator

Jobinhalt

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

Product information

• 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.

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

Job Types: Full-time, Permanent

Benefits:

• Food allowance
• Health insurance

Schedule:

• Monday to Friday

Education:

• Bachelor’s (Required)

Experience:

• Regulatory Affairs: 1 year (Required)

Language:

• English (Required)