Regulatory Specialist

Location: Belfast  |  County Antrim  |  Northern Ireland
Sector: Life Sciences
Consultant: Chris Kerr
Job Reference: CK/HQ283
Salary: £27000 - £32000
Job Status: Permanent / Full Time
Job Title

Regulatory Specialist

Reports To

Snr. Regulatory Specialist    

 
Position Summary

Responsible for supporting the interpretation of requirements and implementation of updates to ensure compliance to MDSAP, ISO 13485: 2016 and MDR for a class III medical device.

Key Areas of Responsibility

The Regulatory Specialist will be responsible for the following activities:

  1. Interpretation of ISO 13485, MDSAP and MDR
  2. Assisting in the identification of actions required to ensure compliance with ISO 13485, MDSAP and MDR
  3. Assisting in providing inputs to the project manager to ensure the creation of project plans for ISO 13485, MDSAP and MDR
  4. Conducting updates to labelling, SOPs, work instructions, trending tools and policy documents to ensure compliance with ISO 13485, MDSAP and MDR
  5. Conducting updates to labelling, SOPs, work instructions and policy documents to ensure compliance with Stryker corporate SOPs
  6. Supporting internal and external audits as required
  7. Supporting regulatory submissions and registrations as required
Qualifications Knowledge Skills
  • Qualifications:

2:1 in Engineering or Science or an equivalent qualification in QA or RA

  • Experience:

Minimum of 2 years’ experience in a regulated medical device or pharma business 

  • Specific Knowledge

An understanding of ISO 13485: 2016

An understanding of MDSAP regulations would be advantageous

Knowledge of 21 CFR part 820

Knowledge of ISO 14971 and ISO 14155 would be advantageous

  • System/Computer Requirements:

Basic Microsoft Office, MS Project, Adobe Acrobat

  • Key Competencies needed for this position?

Attention to Detail

General knowledge of the relevant regulations

Highly developed interpretation Skills

Problem Solving Skills

      Effective Communication Skills

      Highly developed technical writing skills