Regulatory Engineer
The Role:
CLIN-r+ now has an exciting opportunity for a contractor Regulatory Engineer to join our team.
Are you a wizard at compiling gap assessment or Technical Documents (Dossier)? Is you super power to easily spot gaps in Technical Documents and knowing how to remediate them? Do you desire working from home and setting your own hours? Then we want to speak to you.
The role is fully remote so the ideal candidate must have mastered remote
working and have a home office set up that can deal with reviewing multiple documents. The role initially requires a minimum of 10 hours a week availability and as the contractor masters our workflow more hours can be allocated as you need.
This role will be in the Regulatory Affairs team primarily supporting interesting MedTech and Invitro Diagnostic transitions to EU MDR/IVDR. You’ll work with subject matter experts and consultants with documentation, but will also be an important part of the wider team and there is potential for further development.
Please state your availability on your application
Essential Skills & Experience:
- 2+ years of experience within the medical device industry and knowledge of EU MDR regulatory requirements, GSPR checklist, Classification and conformity routes.
- 3 - 5 year’s industry experience as Regulatory Affairs person in the healthcare industry or in a related area such as quality, regulatory, clinical research, or product support.
- Experience with FDA and international regulations, requirements and guidance associated with CE marking document preparations, submissions and reporting preferred.
- Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning
- Microsoft Office proficient with experience working within MS Teams.
- High level of accuracy, attention to detail and delivers high quality results in line with deadlines.
- Knowledge of PRRC would be beneficial
Key Responsibilities:
- Do Gap analysis of clients existing files 510K, EU MDD/IVDD or TGA dossier to use towards EU MDR/IVDR
- Create technical file for FDA, TDA, MDSAP and EU MDR
- Review client information from submissions and technical documents to the appropriate sections of the new technical document for each product.
- Review individual document content relative to current regulations.
- Identify any additional gaps in coverage of the regulations and communicate with the responsible teams the remediation needed.
- Know submissions process and advise on this.
- Able to remain up to date on regulations UKCA, EU MDR, FDA, TGA
- Be able to respond to NB questions and deficiencies, and the client responses
No agency applications please.
