A fantastic remote working opportunity for an International Regulatory Affairs Manager to join a Global Medical Device buisness.
25 days holiday plus 8 bank holidays
This role will act as a bridge between the international regulatory group and the 'core' regulatory team. The role will include coordination of regulatory submissions and development of appropriate documentation and systems in conjunction with both regulatory groups.You will be integral in the development of international strategy and will interact daily with the global regulatory team.
The role will be integral in the development process and provide technical insight into the requirements of international submissions as well as international strategy and function.
You will manage a small team as well as interacting with the global regulatory organisation (LATAM, APAC, EMEA) in a matrix like structure providing guidance for the international regulatory team on ongoing projects and corporate initiatives.
You'll be key in providing details of the international arm of the company regarding strategy and commercial needs to the regulatory and technical groups within the company.
Liaising with a broad range of domestic groups across the business in relation to any changes to project scope, timelines, regulations etc.
Gathering all documentation for new submissions and ensuring high attention to detail when dealing with international country requirements.
Demonstrable submission history experience for US, EU and international as well as knowledge of international submission processes, language skills are also a plus.
Regulatory degree, while not a requirement, would be an advantage.
A number of years' experience within the Medical Device field
For immediate consideration please forward your most up to date CV
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.