Regulatory Affairs Associate

Recruiter
MedAlliance
Location
Glasgow City Centre
Posted
01 Sep 2019
Closes
05 Sep 2019
Ref
1228114227
Contract Type
Permanent
Hours
Full Time
Exciting new opportunity to work in a quickly growing global Medical Device Company who specialises in developing device/drug combination devices to treat peripheral/coronary artery diseases. This is a great opportunity for an experienced RA Associate to be directly involved with global regulations, including FDA IDE/PMA process, EU CE mark process as well as Japan and China registration activities.

Located in Glasgow, Scotland.

Salary offered will be extremely competitive and dependent on experience and what you can bring to our company.

As a Regulatory Affairs Associate, your role will be to:
  • Ensure that our company's products comply with the regulations of the regions where we want to distribute them
  • Keep up to date with national and international legislation, guidelines and Standards
  • Prepare submissions of licence variations and renewals to strict deadlines
  • Be involved with the development of new products with the relevant departments both in-house and with our global colleagues
  • Support and assist with regulatory inspections
  • Review company practices and provide advice on changes to systems
  • Communicate with regulatory authorities for marketing authorisation
  • Review storage, labelling and packaging requirements
  • Review marketing and promotional literature
  • Identify, complete, and file all necessary documentation as required with applicable regulatory bodies (both domestic and international) for product registrations.
  • Assemble, review and update design dossiers and technical files for all products in collaboration with our internal departments
  • Support International Standards Organization implementation and maintenance

Qualifications
  • Bachelor's Degree in Biological or Life Sciences, or equivalent.
  • Minimum of 2 years RA experience in the medical device (or related) industry
  • Good knowledge of EU regulations and FDA regulations
  • Strong communication and problem-solving skills
  • Advanced computer skills
  • Project organisational skills

Our team is a young start-up, heading the UK branch of a global, pioneering Medical Device Company. In this role you will work closely with all other areas of the business on site and with our affiliate offices globally. The role may also offer opportunity to travel internationally as we have teams in both Europe and the US, along with teams in South East Asia. The role is a full-time position, with flexible hours available to the right candidate.