Regulatory Affairs Specialist

My client is a US based dental medical device company, who in the past two years have branched out into the European market. Having grown to 50 people in their German site, they are now searching for an RA professional to join their team.

Responsibilities:

• Prepare and coordinate submissions to European regulatory Bodies.
• Coordinate with product development and R&D teams in the US.
• Act as point of contact with government regulatory agencies.
• Serve as representative for EU regulatory affairs team at process review meetings.
• Coordinate and act as key point of contact on all EU inspections and audits.

Qualifications and Experience:

• 2+ years' experience within a regulatory position in the medical device industry.
• Minimum Bachelors' degree in a relevant field.
• Strong experience and understanding of EU MDR.
• Fluent in English and German.
• Experience in a dental company is a plus.

Application:

If you have any questions, please contact Nick Skouros, specialist recruitment consultant at nskouros@barringtonjames.com.