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Sr. Regulatory Project Manager, Belgium - L

Employer
ClinChoice
Location
Belgium, Antwerp area
Salary
Competitive
Start date
18 Jul 2019
Closing date
15 Aug 2019

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Job Details

Description:
Job Title: Sr. Regulatory Project Manager
Location: Belgium, Antwerp area
Start date: ASAP

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Sr. Regulatory Project Manager to strengthen the team of one of Top 10 Pharmaceutical Companies.

For our client-facing positions, you must be confident and be able to drive the role and yourself and to work autonomously. You will have a close relationship with our Line Managers, who will provide you with mentoring and guidance. Most of our roles are permanent positions with CROMSOURCE and you will be working on studies for just one client. We are open, friendly and approachable and aim to support you through the recruitment process every step of the way.

Job Description:
This individual will provide support to the Regulatory Diagnostics team for registration of Software as Medical Device and Companion Diagnostics in the EMEA region.

Key Job Activities:
  • Prepare or review regulatory strategies and plans for Medical Devices and In Vitro diagnostics.
  • Perform regulatory assessments for product qualification as medical device.
  • Coordinate product regulatory GAP assessments against MDR 2017/745 and relevant harmonized standards.
  • Create or review Technical Files and design dossiers for submission in EMEA. This might involve interacting with external development parties.
  • Coordinate responses to requests from notified bodies and regulatory authorities in order to expedite approval of regulatory submissions.
  • Evaluate regulatory impact of product changes.


Job Qualifications:
  • Bachelors, preferably Masters, degree in biochemistry, microbiology, pharmacy or life-science or health-related discipline with minimum 10 years business experience.
  • Minimum 10 years' experience with regulatory strategies and EU conformity assessments for molecular In Vitro Diagnostics (IVD Dir 98/79/EC) and Medical Devices (Dir 93/42/EEC).
  • Knowledgeable about design controls, software development process, computer system validation and cybersecurity.
  • Familiar with development of PCR tests or next gen sequencing, validation and performance characteristics of such test, clinical validation protocols and reports.
  • Proficient use of digital technology.
  • Working language is Dutch and English; mastering French is an asset.


Personality profile
  • Collaborative team-player with a dynamic personality.
  • Excellent verbal and written communication skills.
  • Detail oriented regulatory leader.
  • Willing to travel throughout Europe (max. 1x/month).


If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001889 . If you would like to discuss the role before applying through the website, please contact Julie.casteleijn@cromsource.com for more information.

Our benefits when working via TalentSource Life Sciences in Belgium:
  • Dedicated Line Manager
  • Employee satisfaction survey - your feedback is important for continuous improvement
  • Annual appraisals development planning
  • Yearly team event
  • New Year's diner
  • Group- and Hospitalisation insurance
  • Electronic meal vouchers
  • Internet reimbursement
  • Company mobile phone (Depending on project)
  • Car with fuel card (Depending on project)


Why choose TalentSource Life Sciences/CROMSOURCE?

TalentSource Life Sciences is a fully dedicated flexible resourcing department at CROMSOURCE, a family owned international, full-service Contract Research Organisation. CROMSOURCE comes from the merger of MSOURCE and CROM and we have been supporting clients with outstanding clinical research and resourcing services since 1994. Successful growth has been achieved by putting high quality and client focus at the heart of everything we do and we are proud to partner with industry leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide.

Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly, family 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. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our current below industry average turnover rates.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are experts providing experts - highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world.

Skills: Regulatory Affairs Manager, Medical Device, Regulatory Location: Belgium, Antwerp area

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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