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Regulatory Affairs Manager (m/f/d)

Permanent contract

Published :

DESCRIPTION

Peters Surgical, a French company, develops, produces and markets single-use sterile medical devices for the operating rooms and for surgeons. As the European leader in medical devices, we have over 765 employees worldwide. Our international dimension allows us to distribute our products in more than 90 countries. Catgut GmbH is a medium-sized company with headquarters in Markneukirchen and since 2021 part of the Peters Surgical Group. Joining Peters Surgical means becoming part of a dynamic structure and participating in the development of a rapidly expanding company. In this respect, we are looking for a :

 

Regulatory Affairs Manager

Markneukirchen, Germany

 

As Regulatory Affairs Manager, you will be responsible for identifying, monitoring and communicating all country- and product-specific regulatory requirements and report directly to the Group Head of Regulatory Affairs.

This includes:

  • Preparation and maintenance of technical documentation for product approvals
  • Support in risk management
  • Assessment of biocompatibility
  • Preparation of clinical evaluations
  • Planning and implementation of conformity assessment procedures
  • Coordination of projects for the implementation of Regulation (EU) 2017/745 and support of the relevant departments in the implementation of regulatory requirements
  • Preparation of international registration documents
  • Regulatory support for new and further developments of the product range
  • Evaluation of product/process changes; processing of change requests
  • Monitoring of regulatory and legal requirements at European level
  • Communication with Notified Bodies and Competent Authorities (on national and international level)
  • Planning, execution and evaluation of tests
  • Interdisciplinary cooperation with the internal departments Purchasing, Sales and Quality
  • Assistance in the planning and execution of qualifications and validations
  • Coordination of the cooperation and subcontracting of external service providers
  • Processing of customer requests for article enhancements
  • Regulatory support of customers

 

In addition to an attractive and secure job in the beautiful Vogtland region, we offer you a motivated team in an international environment, challenging tasks and a varied daily work routine with selfresponsibility, flexible working hours, flat hierarchies, a company canteen and professional development opportunities.

Do you want to take up the challenge and support us actively? Then inspire us with your complete application, including salary requirements and earliest possible starting date, to:
Catgut GmbH
Gewerbepark 18
08258 Markneukirchen
E-Mail: bewerbung@catgut.de

If you have any questions, please do not hesitate to contact Ms. Reinhardt at 037422-5830.

SKILLS

  • Analytical, structured and reliable way of working
  • Affinity for legal texts, leadership skills, high sense of responsibility and good communication skills
  • Willingness to travel on business, especially internationally due to group visits
  • Confident handling of MS-Office programs

YOUR PROFILE

Experience :

Experience in the medical technology industry is an advantage

Training :

Completed studies in the natural science, technical or medical field

Languages

Fluent in written and spoken English

Complementary information :

Send us your application to bewerbung@catgut.de. If you have any questions, please do not hesitate to contact Ms. Reinhardt at 037422-5830.