Job Ref: 214810269

Date: 2021-10-04 15:04:56

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Our Client is looking to recruit a Regulatory Specialist to join their team at their Head Office

This role could either be a hybrid role so the option of work part at home and part in the office

The main aspect of the role are –

General

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 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).

Assist in fulfilling 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.

Create and update as required documentation relating to regulatory processes.

Engage interest and participation of others and has a collaborative approach to working with others.

Actively Committed to team development.

Establish and maintain QMS procedures related to regulatory responsibilities, product licensing, and regulatory reporting.

Support, comply and ensure complicity with Health & Safety regulations, the Company Handbook, Quality and Environmental standards, and all other Company policies and procedures.

Personal training, Skills and Attributes

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

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

• Excellent organisational skills

• Excellent written and oral communication skills

Support their ISO14001 accreditation

• Support their data submission for our Waste Batteries and Accumulators Regulation.

Essential skills

Minimum of 3 years demonstrated ability within the Regulatory Affairs area

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