Job Description

Our client, a leading medical device company, is looking for a Regulatory Affairs Specialist to join their team. If you have the required experience and are up for a challenge, this could be a great opportunity for you. Responsibilities include:

1) Provide support for new product development and transform the on-market product

development documentation in alignment with the latest regulatory requirements

2) Implement the update of technical documentation from MDD to MDR for existing products

3) Focus on the improvement of technical files and risk management documentation.

4) Oversee post-market surveillance and revision of related risk management as applicable

5) Review product and manufacturing process changes, supplier changes and new and revised

engineering protocols and reports and review product labeling updates

6) Ensure compliance with the design control process and with the Quality Management System

7) Maintain product listing, licensing, and all appropriate registrations globally.

8) Work closely with the R&D and Engineering group as well as QA and RA Team

9) Perform other duties as assigned

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the medical device industry is strongly preferred

4) Preference will be given to candidates with recent experience in regulatory affairs

This role is ideal for a qualified, energetic individual who possesses great attention to detail. So, if you’re looking for a rare and exciting opportunity in regulatory affairs and want to do it within a quality company, this could be the perfect role for you - please apply ASAP!

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience

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