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Regulatory Affairs - Senior

U256

DPS Contract Services are looking to recruit a Senior Regulatory Affairs poerson

Category:
Quality
Location:
United Kingdom
Date Posted:
04/06/2019
Days Remaining:
12
Employment Type:
Contract

This position is responsible for supporting the activities of the Design Owning Organiz411071.86497ation (DOO). The candidate will work with the Product Design Owner (PDO) in performing tasks related to regulatory compliance, change control, design control, and risk management for Advanced Surgery products produced under the DOO.

Essential Duties and Responsibilities

Support the PDO in fulfilling requirements for regulatory compliance, design control and risk management activities for Orthobiologic products manufactured.

Lead activities required in the design and development assurance and documentation to maintain regulatory compliance, particularly for the new European Medical Device Regulation (MDR).

Review and execute regulatory gap assessments against existing and new Regulation.

Maintain and remediate Design History Files and Risk Management files for products.

Generate and manage work flow for appropriate change control documentation.

Project management of projects related to design assurance, risk management and DHF remediation.

Support the PDO in gathering information from Subject Matter Experts (SMEs) and technical resources for complaint investigations, change control, and regulatory submissions

Other tasks as required

Knowledge and Skills

Solid communication skills – both written and oral

Organiz411071.86497ational skills and attention to detail

Ability to work effectively independently and in team environment.

Experience working in regulated industry (medical devices, drugs, biologics) is preferred.

Knowledge and experience working with medical device regulatory requirements, design control, change control, and risk management is highly desirable.
 

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