Collins McNicholas

The successful RA Specialist will be responsible for providing Regulatory support through the Design and Development and change control process. You will also plan, prepare and submit regulatory submissions. Provide support to company RA with all international country submissions. Support company goals and objectives, policies and procedures, quality systems, and FDA regulations

RA Specialist responsibilities: 

  • Identifying new regulations and standards that impact regulatory compliance
  • Complete technical review, of manufacturing location process validation documentation in line with MDR requirements and update where required.
  • Support Management review and Management of external 3rd party audits.
  • Provide Regulatory support to new product introduction and product transfers teams.
  • Plan, prepare and submit regulatory submissions for specific target markets for new products, product changes, and re-registration as needed or collaborates with their assigned regulatory specialists on same.
  • Ensures the clinical requirements of the product are adequately addressed.
  • Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
  • Provides support to currently marketed products as necessary including input on change requests, etc.
  • Maintains and organises appropriate Technical files and regulatory records to demonstrate compliance with applicable regulations. 

RA Specialist Requirements:

  • Level 8 degree in a relevant disciplne
  • Previous regulatory experience in a Medical Device environment is essential.
  • Strong computer skills – Change control management; design, process, and system.
  • QMS Internal auditing skills
  • Good customer relation skills
  • Ability to present an independent opinion

First Name

Surname

Your Email (required)

Your mobile (required)

Preferred Collins McNicholas Office (required)

Comment / Cover Letter

Upload CV

In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

Why You Should Use A Recruitment Consultant

Blog: Why choose a recruitment consultant? - Nicola Walsh
Of late I have found myself explaining to family and friends what I do. I had assumed that when I said I am a Recruitment Consultant, they would know… but this is not the case! So, in short, we help companies to hire the best people to fit into their organisation, and we help individuals […]
Read More
  • Find a job
  • Apply
  • Get a job