Job Title: Regulatory Affairs Specialist, Medical Devices
Location: Germany - Munich area
Schedule: Permanent - Full time - Office based (some flexibility to work from home occasionally)
TalentSource Life Sciences is currently recruiting a permanent hire for Regulatory Affairs Specialist to strengthen the team of one of our clients.
Our client is a global provider of innovative solutions for life science companies to improve diagnostics, monitoring, hemodynamic solutions and therapy guidance for critically ill patients and patients at risk.
Main Job Tasks and Responsibilities
- Creation and maintenance of technical documentation for medical device approvals in the European and international markets
- Research of international regulatory requirements and guidelines for relevant changes
- Execution of European and international medical device approval and registration procedures
- Processing of approval and registration amendments
- Advise colleagues on regulatory implications for product development, testing, and manufacturing projects
- Communication with internal and external parties
- Active participation in cross-functional and international projects
Education and Experience
- A university degree in life sciences or medical technology (e.g. chemistry, biology, pharmacy, medicine or optics) or a long-standing background in the healthcare industry is required
- Preferably with medical device experience
- Very good knowledge of English (other languages are an advantage)
- Attention to detail
- Analytical thinking with good problem solving skills
- Ability to act in a multicultural and cross-functional environment
- Flexibility and high commitment
- Knowledge of Windows and Office is expected
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=HQ00002165
or please contact Alexander.Sourounis@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, medical devices
Skills: Medical Devices, Regulatory, Regulatory Operations Location: Germany, Munich Share:
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