Senior Regulatory Affairs Specialist

Description:

Senior Regulatory Affairs Specialist
Location: Alva, FK12 5DQ
Salary: £36,780-£41,110, DOE + Benefits
Contract: Permanent, Full time
Hours of work: Monday to Friday, 37.5 hours
Benefits:
* 34 days leave including bank holidays
* Pension
* Private healthcare
* Employee assistance programme
* Retail discount card.
Be part of a growing global company and help shape our Regulatory Affairs department!
AccuBio Ltd. (manufacturers of In vitro Medical Devices) are currently recruiting for a Senior Regulatory Affairs Specialist.
Senior Regulatory Affairs Specialist – The Role:
To ensure that the Regulatory Affairs (RA) function in AccuBio Ltd performs to a level that allows the organisation to meet its regulatory responsibilities.
Main Responsibilities:
* Maintain current knowledge of IVDD/R industry developments, and relevant quality bodies, standards, and directives; make recommendations regarding any changing requirements to the President.
* Plan and organise day-to-day RA activities, ensuring regulatory processes are followed and within required timeframes.
* Review and compilation of technical files for AccuBio Limited products to meet the requirements of the current 98/79/EC in vitro Diagnostics Directive &/or Regulation as well as other / ROW regulatory authorities, as required.
* Process Owner and Subject Matter Expert for:
* Post Market Surveillance & Performance
* Vigilance Ensure effective management of Customer Complaint reporting assessment, Vigilance reporting & Management of Field Actions.
* Product Labelling (review and approval, including instructions for use, container labels, packaging artwork, promotional and training material)
* Preparation of documentation in support of AccuBio Limited regulatory submissions to comply with regulatory authorities for registrations of products worldwide to gain marketing authorization.
* Notification to regulatory authorities, where applicable, of significant product changes to retain marketing authorization.
* To liaise with partners and regulatory authorities in support of regulatory submissions and vigilance activities.
* Review and approval of product development verification protocols and reports.
* To be involved in AccuBio’s continual improvement in all aspects of cGMP, Compliance and QMS.
Senior Regulatory Affairs Specialist – Key Skills and Experience:
The ideal candidate will be educated to degree level and preferably have some experience of Regulatory Affairs within the medical device or pharmaceutical industry.
Essential
* GCSE or equivalent, a Life Science Degree or equivalent qualification preferred.
* A minimum of 2 years’ experience in regulatory affairs for medical device or In-vitro device manufacturer.
* Interest and background knowledge of science.
* Understanding of Medical Device and/or IVD Directives (MDD / IVDD) and associated ISO standards
* Basic proficiency MS Excel, MS Word and Outlook.
* Self- starter, able to work unsupervised to a high degree of accuracy
* Great attention to detail with good report writing skills
* Clear communication in spoken and written form
* Effective time management and prioritisation skills
* Proactive and able to work effectively independently or within a team
Due to the volume of applications, we are unable to respond to all applications. If you do not hear from us in four weeks, please assume that your application has been unsuccessful.
If you feel you have the necessary skills and experience to be successful in this role, click on “APPLY” today, forwarding an up-to-date copy of your CV for consideration in the first instance.
No agencies please