Regulatory Affairs Specialist - Dundee, United Kingdom - Abbott Laboratories

Abbott Laboratories

Verified Company

Dundee, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

About Abbott

At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives.

In 196 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

The Opportunity

Abbott Rapid Diagnostics ARDx (formerly Alere) is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. We are currently recruiting for a
Regulatory Affairs Specialist based in our Dundee site.

What You'll do
As a Regulatory Affairs Specialist you will be primarily responsible for the administration and development of the Switzerland Person Responsible for Regulatory Compliance (PRRC) and UK Responsible Person (RP) activities within the Abbott Rapid Diagnostics division according to appropriate procedures and processes

More specifically:

Ensure that appropriate oversight of activities is maintained and any updates required are actioned through appointed Quality Management system(s)
Demonstrate commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies
Act as an initial and ongoing point of contact for customer sites, external regulators and other parties for Swiss PRRC and UK RP related requests
Collation of electronic and paper documents to allow the registration or removal of products according to procedures
Review and update internal / external databases' details for products and manufacturers
Administer, deliver and forward documents related to requests from manufacturers
Communicate any complaints, as appropriate to manufacturers

Required Qualifications and Skills

Experience in medical devices or IVD regulation or regulatory activities
Bachelor's Degree in a related field is required
Experience of PRRC activities previously is desirable but not essential
Experience user in MS Office suite
Excellent administrative, organisational and business support skills, with the ability to multitask and to work calmly under pressure
Ability to coordinate meetings, to drive results and build relationships
Demonstrated administrative, written and verbal communication, negotiation and influencing skills
Organised, detail oriented, have a high level of confidentiality

As you'd expect from a global healthcare company, Abbott has health, wellbeing and financial benefits that help provide security for you and your family.

We offer a fantastic range of benefits including competitive salaries, a superb defined contribution pension scheme, share ownership scheme, life assurance and much more.