Regulatory Affairs Specialist Opportunity

3 hours ago


Belfast, United Kingdom Lifelancer Full time

Are you looking for a challenging and rewarding career in regulatory affairs?

We are seeking a highly motivated and organized Regulatory Affairs Co-op to join our team at Stryker Belfast. As a key member of our HeartSine AED Regulatory Affairs team, you will play a vital role in upholding Stryker's reputation as the leading provider of public access defibrillators worldwide.

This one-year placement student opportunity offers valuable experience and training in an increasingly sought-after aspect of medical device regulatory compliance. You will be responsible for assisting with the preparation and maintenance of regulatory documentation for product registration, change assessment, and new product development.

You will also attend and contribute to internal design reviews and the investigation and analysis of competitor products and systems. Additionally, you will have the opportunity to become involved in product design, development, and marketing activities.

  • Key Responsibilities:
  • Assist in preparation and issue of product certification and business exception letters.
  • Support product registration and renewals.
  • Support the supplier change request process through assisting with regulatory change assessment and documentation of changes.
  • Provide administrative support for New Product Development regulatory activities.
  • Support the development of the regulatory quality management system.
  • Work in accordance with the Stryker Belfast Quality Management System.
  • Maintain awareness of the Company Health and Safety Policy and Fire Evacuation Procedure.
  • Assist with other regulatory tasks deemed necessary by the Associate Manager, Regulatory Compliance.

Requirements:

  • Studying for a third-level qualification in design engineering, electronics, or biomedical engineering or related discipline.
  • Effective written and verbal communication skills.
  • Understanding of basic technical documentation.

What We Offer:

  • A competitive salary of $40,000 - $50,000 per annum.
  • A comprehensive benefits package.
  • The opportunity to work with a global leader in medical technologies.
  • Professional development and training opportunities.

Stryker is a global leader in medical technologies and together with its customers, is driven to make healthcare better. If you are a motivated and organized individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.



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