CROMSOURCE

Regulatory Affairs Specialist, Belgium - L

Company
CROMSOURCE
Location
Belgium
Salary
Competitive
Posted
01 Feb 2021
Closes
02 Mar 2021
Ref
HQ00002402
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Description:
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Regulatory Affairs Specialist for one of the most innovative pharmaceutical company in the world.

For our client facing positions, you must be confident, be able to drive the role 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 projects for just one client. We are open, friendly and approachable and aim to support you through the recruitment process every step of the way.

The Authorized Representative Quality and Regulatory Coordinator is supporting the business' AR-PRRCs and is responsible for the implementation of the AR procedures under the EU Medical Devices Regulation (2017/747) for Global Surgery businesses.

The Authorized Representative Quality and Regulatory Coordinator will establish the required processes in alignment with EU AR Council members across the MD businesses.

Position Duties & Responsibilities:
  • AR agreement maintenance Verification of Manufacturer's compliance for new MDR products certification incl. lifecycle, change and record management etc
  • Completes verification measures per process Verifies data Notifies Manufacturer about gaps / required corrections and completes verification once addressed by Manufacturer Registration of AR (Eudamed) incl. lifecycle management Initiates and maintains registration measures per process Actor (AR) registration in Eudamed Shares Single Registration Number (SRN) with Manufacturer asap and with other EOs upon request If informed by Importers about potential actor registration gaps or mistakes, corrects immediately if required Manages AR registration related fees and invoices if applicable
  • Verification of Manufacturer's device data registrations (Eudamed) incl. lifecycle, change and record management etc
  • Provide regulatory and quality support to the Supply Chain End to End EU MDR Pilot Process Address Economic Operators requests (Deliver Quality) during the hyper care period including support and training to access relevant documents, address question and liaising with the legal manufacturer to ensure resolutions on Non conformities escalated by the Deliver Quality Organization
  • Managing CA requests incl. NC/CAPA, FSCA related Supporting CA Inspections and NB audits Other per AR SOP 100674766
  • Responsible for communicating business related issues or opportunities to next management level
  • For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures


Education, Experience and Skills:
  • University/Bachelor's Degree or Equivalent
  • 2-4 Years Work Experience
  • Working knowledge of the European Regulation and laws as it pertains to Medical Devices
  • Practical knowledge of ISO13485
  • Experience in the Medical Device industry or medical field
  • Demonstrated knowledge of manufacturing principles and practices, and procedures
  • Knowledge of specific business practices and software and software applications
  • Ability to define problems, gather information, plan and execute objectives
  • Demonstrate project management skills with strong results orientation
  • Teamwork and leadership skills
  • Strong communication, influence and presentation skills
  • Ability to effectively communicate to top management
  • Ability to perform duties in accordance with policies and procedures and in to comply civil rights requirements
  • Fluent in English (required) and in another European language (e.g. French, Dutch, German)


The Benefits of Working for TalentSource 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


Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE 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 the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

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.

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/job-information/?job-id=HQ00002402

or please contact Vanessa.Verdickt@cromsource.com for more information.

CROMSOURCE is an equal opportunities 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.

Keywords: Regulatory Affairs Specialist
Skills: ISO 13485, Manufacturing, Medical Devices, Project Management, Regulatory Location: Belgium Share:

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