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Role Filled
Regulatory Affairs Specialist
Scientific Supplier
Regulatory & Compliance
Remote - UK
£40,000 - £40,000
Diagnostics
Role Overview
Being responsible for ensuring that every product their company sells meets relevant government legislation, and that patient safety and efficacy are at the forefront of business activities.
Company Information
This company is is an integrated company, developing and manufacturing the instruments, reagents, and software needed for in vitro diagnostics and providing sales and support services to more than 190 countries and regions worldwide.
Role Requirements
Key Responsibilities:
· Write and analyse technical documents to support regulatory submissions. (E.G. CLP, REACH, SCIP, Waste Disposal)
· Maintain technical files used for UKCA / MHRA registration.
· Risk assess and investigate reports of adverse incidents in relation to post-market surveillance.
· Respond to questions from regulatory authorities professionally and within agreed timelines.
· Monitor and report on progress of safety corrective actions (FSCAs).
· Fulfill requirements of the UK Responsible Person.
· Manage activities such as audits, inspections and product recalls.
· Contribute to the development or implementation of business unit strategic and operating plans.
· Support our ISO14001 accreditation.
· Support the BMS team with regulatory aspects for data submission.
Person Specifications
Personal Specification:
· Minimum of 3 years demonstrated ability within the Regulatory Affairs area
· Hold a bachelor’s degree in a technical or scientific field
· Strong analytical / critical thinking skills with the ability to multitask.
· Have a high level of integrity, initiative and self-motivation.
· Excellent written and verbal communication skills with the ability to listen, articulate and advocate.
· Strong Microsoft Office skills.
· Ability to identify compliance risks and escalate when necessary.
Package
Base salary £40,000 per annum
Company Bonus (company discretion) up to £5,500 per annum
Home-based – 30 hours per week
Enrollement to Bupa, Contributory Pension, Death in Service, Income Protection Insurance
28 days annual leave
Locations
Aberdeen
Accrington
Airdrie
Alderney
Aldershot
Alfreton
Alloa
Altrincham
Amersham
Andover
Annan
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Ashford
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Aylesbury
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Banbury
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Previous Listing
Date Updated
20 Oct 2023
Job reference
71851
Categories
Full Time
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