Regulatory Affairs Specialist

​In this exciting opportunity, Vision Executives have partnered with one of the global leaders in ophthalmic medical devices who are expanding their RA team due to multiple new products coming to market. They are looking for a Regulatory Affair Specialist to provide and maintain regulatory support, supply regulatory input and ensure compliance with standards and medical device regulations worldwide. The candidate will also take on the role of “Person Responsible for Regulatory Compliance”.

This position is based in Northern Germany, and is offering a competitive salary, bonus and great benefits package.

The key responsibilities include:

• Carry out the duties of PRRC as defined in Article 15.6 of EU 2017/745
• Carry out the duties of AR as defined in Article 14(2) of Directive 92/43/EEC, and Article 11 of Regulation (EU) 2017/745
• Provide support for registration activity in your assigned geographic region(s) this includes (but is not limited to):

• Developing registration and launch plans with the regional sales managers to ensure that registration work is under control
• The preparation and submission of registration dossiers, and their submission and remediation.
• Establish and maintain regulatory information systems such as technical documentation, quality records, routine reports and regulatory agency communications
• Interpret existing and/or new regulatory requirements/guidelines and standards as they relate to company products and procedures

• Ensure compliance to global regulatory requirements and company policies
• Provide input to Company activities including the risk management process, process and procedure improvements, management review and support new product development activities
• Review document and product changes for regulatory submission impact
• Support equipment, system and process development in-house and with suppliers
• Interface and co-ordinate with regulatory agencies; provide regulatory input and appropriate follow-up support to inspections and audits
• Participate on product development teams to ensure regulatory requirements are incorporated into the development process
• All such other tasks as may be reasonably required to support the activities of the Regulatory Affairs department and the Company

 
Suitable candidates will be fluent in English and German and have 2-3 years’ experience in a Regulatory role in a medical devices company.
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To apply for this position please email us, call us or submit you CV via out contact page quoting the vacancy reference: R1405RAS