eResearchTechnology GmbH
Nathalie Fischer
Tel.: +4993057206283
https://www.ert.com

Manager Regulatory Affairs (f/m/d) | Managerin/ Manager (m/w/d) Regulatory Affairs

Clario. (the best of ERT and Bioclinica) delivers the leading endpoint technology solutions for clinical trials.


Through experience gained from over 19,000 clinical trials delivered in support of 870 regulatory approvals, Clario. fuses scientific expertise and global scale into the broadest endpoint technology platform to enable pharmaceutical, biotech and medical device partners to transform lives.


Through Trial Anywhere™, Clario has mastered the ability to generate rich evidence across all trial models: decentralized, hybrid and site-based clinical trials. With 30 facilities in nine countries across North America, Europe and Asia Pacific, Clario.’s global team of science, technology and operational experts has been delivering the richest clinical evidence for nearly 50 years. 

 

We are looking for a 

 

Manager Regulatory Affairs (f/m/d) | Managerin/ Manager (m/w/d) Regulatory Affairs

 

to join us in our Estenfeld (near Würzburg) site to ensure regulatory compliance for medical and non-medical devices and software.

Become the interface to regulatory authorities for device registration, start your career at Clario . and get to know our global team. 

 

As Manager Regulatory Affairs (m/w/d) you will

  • Implement and maintain an ERT wide medical and non-medical device and international regulatory strategy andbprovide this regulatory strategy to all stakeholders in development projects and change projects.
  • Prepare, review and compile submission strategies in case of new products or changes used in clinical trials.
  • Monitor and evaluate the impact of regulation changes for existing products in the clinical trial market. 
  • Compile, prepare, review and submit regulatory submission to authorities. Establish active contact to national authorities in different countries (US, Europe, APAC etc.).
  • Lead the risk management of Clario./ERT's medical devices and actively support an ERT-wide risk based approach.
  • have managerial responsibility and leadership for the Regulatory Affairs Group 
  • Assure continued compliance by identifying and correcting gaps in procedures and designing and presenting training programs to educate associates at all levels within the organization.
  • Evaluate and present ERT's strategy on borderline products (eg. clinical decision software, AI).

The ideal candidate (f/m/d) should meet the following requirements:  

  • Bachelor’s Degree (BS or BA) in technical discipline, preferably in a life science / medical device area, or equivalent combination of education and experience in domestic / international submissions and / or regulatory compliance.
  • 3+ years working experience in regulatory affairs for a medical device or life science company.
  • Knowledge of 21 CFR 820, ISO 9001/13485 standards and ICH/GxP 
  • Previous domestic / international submissions experience (510(k), CE – mark, etc.)
  • Fundamental knowledge of the regulatory directives and laws in key global markets.
  • German and English Fluent 
  • Team oriented with excellent communication, analytical, and organizational skills
  • Willingness to travel internationally (<15%)

If any of the following qualities apply to you, feel free to highlight them too in your application materials:

  • Other applicable regulatory standards especially ISO 14971, ISO 62304, ISO 62366
  • Third language 
  • Leadership experience and employee management in Regulatory Affairs department

What can you expect from us?

  • Flexible working hours and working time accounts to support the work-life balance
  • Support your professional development through internal and external training and certification programs
  • Modern office building with an on-site canteen offering freshly cooked local dishes (with vegetarian option)
  • Competitive Salary plus Annual bonus target 
  • Company pension scheme
  • The office in Estenfeld is well connected to the transport network. Free onsite parking is available, and for public transport users, ERT pays the costs of a ticket for the WVV (Würzburger Versorgungs- und Verkehrs GmbH)
  • Employee Exchange Programs, as great opportunities to learn more of what others do:
    - Global employee exchange program, meaning you can apply to work in any of our global locations for 4 weeks
    - Local 8 hour exchange program where you can work in another department for 8 hours
  • We have both social and wellness committees

We look forward to receiving your application. Please indicate your salary expectations and your availability and send your application by using our Clario | ERT career page. 

 

You want to work at Clario. | ERT but this sounds not like the right job for you? Just look at our other Estenfeld opportunities: https://careers2-ert.icims.com/jobs/search?ss=1&searchLocation=13183-13187-Estenfeld

 

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eResearchTechnology GmbH

Sieboldstr. 3, 97230 Estenfeld

Tel. +49 9305 720-60

Fax: +49 9305 720-70

 

 

eResearchTechnology GmbH
Nathalie Fischer
Tel.: +4993057206283
https://www.ert.com
Ansprechpartner

Nathalie Fischer