Senior Regulatory Affairs Associate - Based Glasgow x2




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Reference: 6229

We are currently recruiting for an exciting new opportunity with a dynamic and supportive Healthcare organisation. Our client has an extensive product range within the Vascular market. This exciting role will be working as a Senior Regulatory Affairs Associate based in Glasgow. The main purpose of this role is to perform Regulatory tasks as required to ensure regulatory compliance and work towards meeting quality objectives as stated in quality system as applicable.

BSc Hons Degree.
Regulatory experience within a Medical Device or Pharmaceutical environment is essential.
A current driving licence with no more than 6 points.
Able to communicate with external parties:
Regulatory Authorities, Customers, Distributors, Notified Bodies, Competent Authorities.

Role Responsibilities:
Preparation of regulatory documentation and submissions for product approvals.
Development of regulatory plans/strategies for new products and changes to existing products.
Participation in Design Control, Risk Management and Post Market Surveillance activities.
Production and review of design dossiers, technical files and change assessments.
Review and preparation of regulatory paperwork in accordance with International standards and new regulations.
Review of product packaging, labelling, IFUs and marketing literature for compliance with specific country regulations.
Provide regulatory input to functional groups as required.
Participate in review of RA procedures.

Role Specific Competencies:
IT literate with strong analytical skills.
Flexible “can do” attitude needed to thrive in a fast-growing company.
Innovation, tenacity and drive to ensure success.
Self-motivation, persuasiveness and competitiveness.

Recruitment Process:
2 stage process.

Flexible salary and benefits DOE.

Evolve Selection is a leading UK recruitment and contract sales organisation (CSO), operating within the Pharmaceutical, Healthcare and Medical Device sectors. We offer a highly comprehensive range of permanent recruitment and flexible contract sales solutions.

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