Job Ref: 214798422

Date: 2021-10-01 15:19:14

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Homeworking (Headoffice based in Milton Keynes)

Hours: 37.5 (option to work Part-time)

Salary: £55,000 + Company bonus

Our prestigious and award-winning client is currently looking to recruit a Regulatory Affairs Specialist within a Top 10 global business and a leading supplier of Haematology and Coagulation products. This is a newly created position for innovative Regulatory affairs professional to join their highly successful team

With support from Regional Headquarter regulatory teams and local Product Managers you will support and lead the company UK’s regulatory activities and requirements associated with new product release requirements, UK MDR2002, IVD-R 2017, UK REACH, CLP, Product labelling, Product registration, post-market vigilance and management of adverse incidents. This will include management of both our clients’ own products as well as 3rd party

Essential skills

* Minimum of 3 years demonstrated ability within the Regulatory Affairs area

* 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

Desirable skills

* Experience within the IVD industry

* Experience with product registration

* Documented training on current medical device standards and regulations (e.g., UK MDR, ISO 13485, etc.)

* Previous experience with EU REACH compliance.

* Hold a bachelor’s degree in a technical or scientific field.

Key Responsibilities

Writing and analysing 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 vigilance.

Submission of Field Safety Corrective Action Reports (FSCARs) to Regulatory Bodies

Respond to questions from regulatory authorities professionally and within agreed timelines.

Prepare, distribute and monitor customer acknowledgments of FSNs

Monitor and report on progress of safety corrective actions (FSCAs).

Manage activities such as audits, inspections and product recalls.

Staying ahead of regulatory procedures, guidance documents, standards, and changes in regulatory climate.

Ability to influence, guide, engage and train colleagues in regulatory requirements.

Support ISO14001 accreditation

Excellent Company Benefits

Competitive Salary, Holiday Entitlement 28 days plus (8 days bank holiday), Bonus, Pension, Health Care Insurance (BUPA), Cash Plan (Simplyhealth), Income Protection Insurance, Educational Grant Scheme, Employee Assistance Program, Life Insurance 6 times the annual salary, Perkbox, Gym membership

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