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Regulatory Affairs Administrator, Belgium - M

Employer
ClinChoice
Location
Belgium
Salary
Competitive
Start date
10 Feb 2020
Closing date
11 Mar 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Description:
Job Title: Regulatory Affairs Administrator

Location: Belgium - Leuven area

Schedule: Permanent - Full Time - Office based

TalentSource Life Sciences, a division of CROMSOURCE, is looking for a Regulatory Affairs administrator to work with one of our top 10 Medical Device clients in the region of Leuven.

Responsibilities
  • Basic knowledge of European and some national Regulations for medical devices to be able to take over some daily Regulatory Affairs (RA) tasks of the RA Expert, Specialist and Officer (eg application of certificates, maintenance SharePoint, be able to reply to daily questions of sales branches, …)
  • Basic knowledge of standards applicable to medical devices
  • Product knowledge
  • Prepare routine registration files that can be compiled based on existing examples
  • Assist in the preparation of more complex registration files
  • Assist in sending out and following up on change notifications
  • Assist in the preparation of replies to regulatory authorities
  • Assist in application of documents/certificates needed for these registrations
  • Maintain registration database, closely follow up on registration approvals and share with Business Unit/sales
  • Have basic knowledge of labelling requirements for medical devices
  • Support in the coordination of translation processes and labelling review processes
  • Prepare and maintain label copies for approved labelling and IFUs
  • Assist in review of promotional material
  • Act as master file coordinator for the electronic documentation system
  • Support organisation of record keeping of external documents
  • Co-assist in input, follow-up to closure of the customer product complaints between Sales and the manufacturers and for all products with primary focus on processing of samples involved in product complaints
  • Provide administrative support in the preparation, issue and follow-up of FSCAs till completion
  • Provide support in approval of return order in SAP, registration and follow-up in FSCA databases
  • Support in the preparation of documentation requested by sales branches for participating in tender business
  • Provide and maintain RA information in regulatory information management systems
  • Support in listing requests within ERP system


Education, Experience and Skills
  • Bachelor degree in sciences with an interest in administrative tasks OR experience in administrative support to regulatory activities
  • Experience in and knowledge of regulations and quality systems for medical devices is an asset
  • Background as lab assistant, lab technician - or an education in that domain is an asset
  • Good working knowledge of English (written and spoken). Other languages can be an advantage
  • Familiar with Microsoft - Office in general, and willing to learn and work with software programs
  • Accurate and well organised in performing requested tasks, team worker


Our benefits when working in Belgium
  • Competitive Salary
  • Group and hospitalisation insurance
  • Electronic meal vouchers
  • Internet reimbursement
  • Company Car with fuel card depending on the function
  • Dedicated Line Manager
  • Regular face-to-face or phone meetings with line manager
  • Full annual performance review process
  • Ad-hoc team events and end of year party
  • Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
  • Employee satisfaction survey - your feedback is important for continuous improvement


If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002123

If you would like to discuss the role before applying through the website, please contact vanessa.verdickt@cromsource.com for more information.

Why TalentSource Life Sciences/CROMSOURCE

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

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.

Our key approach is to equally value our clients and our own people. Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel through our dedicated training team, focused on employee development. We also understand the importance of a good work-life balance and we offer flexible solutions for a high number of positions.

The success of these core values are evidenced by our below industry average turnover rates.

By joining our 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.

CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

How can we help you on your next career move? Learn more on LinkedIn, Pharmiweb, Facebook, Twitter, and Glassdoor.

Keywords: Regulatory Affairs Administrator

Skills: SAP, Administration, Medical Device, MS Office, Quality Management System, Regulatory Location: Belgium Share:

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Company

ClinChoice

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.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom

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