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Regulatory Manager (m/f/d)

Date: Apr 28, 2021

Location: Prague, Czech Republic, CZ, 50003

Company: Heraeus

[title]
Regulatory Manager (m/f/d)
Location Hradec Kralove
Permanent 
Full Time
 

Imagine a job where you will have the opportunity to do exciting and challenging work, while collaborating with extraordinary colleagues. A company that invests in you and your career, providing the training, mentoring, development and support you need to be successful now and in the future. If you want a career without limits with a market-leading family-owned, global company where you can make an impact, then imagine an opportunity at Heraeus. Every day, our worldwide team of approximately 14,900 employees are bringing forward new ideas and solutions that are impacting and transforming everything from healthcare to renewable energy to e-mobility to high-tech and telecommunications.

 
 

Roles and Responsibility:

  • As regulatory MGR you will be responsible for preparation and submission of regulatory documents for existing and newly launched products in compliance to current regulation (EN ISO 13485, US FDA 21 CRFR, EU Medical Device Directive and EU Medical Device Regulation)
  • The Creation, submission and maintenance of device regulatory files will be under your responsibility
  • You will provide Regulatory support and guidance to our customers,
  • In your area you will be responsible for creation of quality agreements and regulatory assessments related to customer complaints and incident reporting as well as for DMRs, DHFs and Risk Managment files
  • You will provide support to the global regulatory group
  • Training for site team on regulatory affairs related activities will be a part of the role.
  • You will represent HMC during audits of Regulatory authorities and customers 
  • The Regulatory Manager also is the Activity owner for design control in our facility

 

What is required for this role:

  • You have a university degree preferred in sciences
  • You can proof professional experience of at least 5 years (f.e. quality assurance, pharmaceutical  biotechnology or preferably in medical devices)
  • Knowledge of regulation in medical enviroment
  • Furthermore, you are well-organized, independently working and communicative person
  • You are able to work collaboratively across the team and cross functionally
  • Excellent written and verbal communication skills in English complete your profile