Senior Regulatory Specialist

Location: Belfast  |  County Antrim  |  Northern Ireland
Sector: Life Sciences
Consultant: Chris Kerr
Job Reference: CK/HQ282
Salary: £32000 - £35000
Job Status: Permanent / Full Time
Job Title

Snr. Regulatory Specialist

Reports To

Manager RA/QA   

 
Position Summary

Responsible for leading a team of regulatory specialists in 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 Senior Regulatory Specialist will be responsible for the following activities:

  1. Overseeing interpretation of ISO 13485, MDSAP and MDR
  2. Overseeing the identification of actions required to ensure compliance with ISO 13485, MDSAP and MDR
  3. Providing inputs to the project manager to ensure the creation of project plans for ISO 13485, MDSAP and MDR
  4. Overseeing and conducting updates to labelling, SOPs, work instructions, trending tools and policy documents to ensure compliance with ISO 13485, MDSAP and MDR
  5. Overseeing and 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
  8. Managing the regulatory team on a day to day basis
Qualifications Knowledge Skills
  • Qualifications:

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

  • Experience:

Minimum of 5 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

      Organisation of projects and teams

      Effective Communication Skills

      Highly developed technical writing skills

      Highly developed decision-making skills