Regulatory Affairs Specialist, Germany - L

ClinChoice
Germany
Competitive
09 May 2022
08 Jun 2022
HQ00002846
Regulatory Affairs
Full Time
Contract
Experienced (non-manager)

Description:
Location: Germany - Home and office based

Schedule: Full Time, Contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds....

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Regulatory Affairs Specialist to join one of our clients, one of the most innovative pharmaceutical company in the world.

CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Scope of the role:

The new UKCA regulations which were developed by the UK Competent Authority have to be fulfilled by medical device manufacturers for compliant product distribution.

The overall goal is to achieve UKCA registrations and UKCA product compliance by July 1st, 2023.

Main Job Tasks and Responsibilities:

  • Development of change submission packages for submission to the UK Approved Body to obtain UKCA registration certificates for legacy products
  • Development of NPI submission packages for submission to the UK Approved Body to obtain UKCA registration certificates
  • Review of labelling for compliance with UKCA regulations
  • Supporting QA on process development for the RA part in UKCA related processes
  • Product registrations in the MHRA database - Development of UKCA Tech Files and UKCA DoCs for one of the client's European legal manufacturers
  • Provide cross-functional guidance on UKCA regulations
  • Supporting the UK responsible person on RA related activities
  • Change impact assessments for UKCA requirements
  • RA releases for UK in SAP

 


Education and Experience:

 

 

  • Life science university degree preferred but also long-term Regulatory Affairs work in industry/Notified Bodies sufficient as qualification
  • 3-5 years Regulatory Affairs background (product registrations) in medical devices preferred (all regions accepted) but also Pharmaceutical or consumer Regulatory background accepted

 


Specific Role Requirements and Skills:

 

 

  • Willingness to do hands on Regulatory Affairs work
  • Strong attention to detail and accurate work required
  • Work in a cross-functional, international, diverse team
  • English language knowledge required, more languages are an advantage

 


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 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.

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, Medical Devices, Pharmaceutical, Pharma, Freelance, Temporary, CRO, Contract Research Organisation, Outsourced, Sponsor-dedicated
Skills: Regulatory Affairs Associate, Clinical Research Organisation, CRO, Medical Devices, Pharma, Pharmaceutical, Regulatory Location: Germany Share:

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