Regulatory Affairs Professional

4 days ago


Belfast, United Kingdom Lifelancer Full time

Job Overview

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Stryker, a global leader in medical technologies, is seeking a Regulatory Affairs Professional to join its team in Belfast, UK. As a key member of the HeartSine AED Regulatory Affairs team, you will play a crucial role in upholding Stryker's reputation as the leading provider of Public Access Defibrillators.

The successful candidate will be responsible for preparing and maintaining regulatory documentation for product registration, change assessment, and new product development. You will also attend and contribute to internal design reviews, investigate and analyze competitor products and systems, and provide administrative support for New Product Development regulatory activities.

Key Responsibilities:

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  • 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.">
  • 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:

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To be considered for this role, you should have a third-level qualification in Design Engineering, Electronics, or Biomedical Engineering or a related discipline. High-performing marketing undergraduates will also be considered. Essential skills include effective written and verbal communication, reporting, and problem-solving abilities, as well as an understanding of basic technical documentation.

Benefits:

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This internship offers valuable experience and training in an increasingly sought-after aspect of medical device regulatory compliance. You will work with a talented team to make healthcare better, impacting more than 150 million patients annually.

Salary:

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The estimated salary for this position is £25,000 - £35,000 per annum, depending on qualifications and experience.

About Stryker:

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Stryker is a global leader in medical technologies, working alongside customers to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine.

About Lifelancer:

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Lifelancer is a talent-hiring platform connecting professionals with opportunities in Life Sciences, Pharma, and IT domains.



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