Regulatory Affairs Specialist Ii - Basingstoke, United Kingdom - Thermo Fisher Scientific

Thermo Fisher Scientific

Verified Company

Basingstoke, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

The job:

You will be a member of the MBD Regulatory Affairs Market Access Team

and working as part of a combined team of Regulatory Affairs Professionals both site based and remote based colleagues.

What will you do?

To ensure timely in country registration for MBD licenced IVD products for new market or licence renewal in International Markets according to MBD annual prioritised plan.
Work within Market Access team to ensure accuracy of project information and requirements on incoming project requests.
Work with key regional collaborators (regional RA Commercial teams, etc) to facilitate the timely completion of projects and provide updates on a biweekly basis in regularly scheduled meetings.
Compile technical file data from various sources and working with other departments and legal entities to generate data.
To be assigned change notification activities in various countries as instructed by business needs.
To continuously keep abreast of regulatory knowledge making sure to understand regulations in various regions and their impact on current and future business activities.
Handling compliance activities in ROW countries to ensure continued business and compliance with local regulations using the latest regulatory software packages.
Handle Growth Projects such that products prioritised by the business can be steadily registered in the identified region.
Work timely with Regional RA and Product RA to answer Competent Authority Questions.
Reviewing documentation and obtaining authentication from country embassies, UK FCO, etc as dictated to by local regulatory requirements.
Training of new staff in MA processes to ensure they are competent and capable of leading registration projects for products, processes and systems.
Embody Thermo Fisher values and ethos.
Be an Ambassador for Regulatory Affairs in Thermo Fisher and actively participate in Town Halls.
Utilise internal training available including Continuous Improvement (PPI ).
Be part of a team combining both on site based and remote based colleagues participating in team meetings and lunch and learn sessions.

Who are we looking for?

Degree in Medical/Pharmaceutical Regulatory Affairs or related bioscience field including Microbiology and Chemistry. degree is not required
Some Knowledge of IVD Directive (98/79/EC), US 21 CFR Part 820 and 510(k) submission process and applicable ISO Standards & or submission process for International Markets
Substantial experience within the IVD or medical device industry
Excellent IT skills

Preferred Skills/Experience:

Excellent attention to detail
Ability to plan multiple tasks and effectively prioritize activities
Effective communicator with management, peers and internal customers
Capability to drive assignments to completion
Good planning and organizational abilities
Proactive with proven ability to work under own initiative, and strong team player
Effective project management skills
Ability to work in a matrix organization
Problem solving skills and confidence to lead
Team management /leading experience is an advantage

With Thermo Fisher Scientific, it's not just a career. It's a chance to realise your best - professionally and personally.