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Job titleRegulatory Affairs Specialist – Germany
Job typeMeditech
Salary EUR
LocationEurope
Bonus PackageBonus Package
Job description

Do you want to work for a market leading medical devices company? This is a great opportunity to join our client’s growing entity in Germany as a Regulatory Affairs Specialist.  
 

The company 

Our client has worked closely with cataract surgeons throughout their history to lead the way in the innovation of IOLs and ophthalmic devices, making them a key market player in the development of new IOL products and ocular therapeutics. Passionate about improving sight worldwide, they focus on achieving the very best in patientcare. 

Their portfolio is broad and varied, including monofocal and premium IOLs, surgical devices and OSD solutions. This is supported by a strong Research and Development branch who are constantly working on developing new products using their extensive technical expertise. 
 

The role 

As Regulatory Affairs Specialist, you’ll carry out the duties of the Person Responsible for Regulatory Compliance (PRRC) and the Authorised Representative as defined in the respective EU directives.  

Responsibilities include: 

  • Providing support for registration activity in your assigned territory  

  • Ensuring compliance to global regulatory requirements and company policies 

  • Providing input into risk management process, procedure improvements, and reviews 

  • Supporting new product development activities 

  • Reviewing document and product changes for regulatory impact 

  • Supporting equipment, system, and process development  

  • Co-ordinate with regulatory agencies 

The requirements 

You will have experience in a Regulatory role in a medical devices company – including direct interaction with regulatory authorities, as well as… 

  • Degree or equivalent in a scientific disciple, medicine, pharmacy, engineering, or law 

  • Prior experience in a regulatory affairs/QMS role 

  • Familiar with Quality System concepts, practices, and procedures (e.g., ISO 13485, MDSAP) 

  • Familiar with the Medical Device Directive and Medical Device Regulation 

  • Experience working across export markets and dealing with international distributors 

  • Familiar with databases and business management systems (ERP) 

  • Excellent written and verbal communication skills 

  • Good IT literacy skills (including Microsoft applications) 

  • Ambitious, with a passion for continuous improvement 

  • Fluent in English and German 

 

Important information 

FMC Contact for this role: Ryan Tosh (ryan.tosh@fmctalent.com) 

Reference number: 10355 

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    Updated on 2017-08-07T17:04:38+00:00, by Matthew Graham.