Headquartered in Chichester, Deltex Medical Ltd. is a leader in fluid monitoring systems in the healthcare environment. The company’s technology has been proven to enhance patient care whilst reducing the overall cost to the healthcare provider.
As a pioneer and leader in its field, Deltex is an exciting and dynamic environment place to work with career opportunities across a variety of roles and functions. The company is currently seeking the following people to join its team:
Regulatory Affairs Associate/Officer
This regulatory position is intended to assist in ensuring all products are placed on global markets with the highest level of compliance according to the recognised regulations, specifically those of the EU, US, and Canada. The successful candidate will be responsible for creating and maintaining associated technical documentation such as Technical Files, U.S. FDA 510(k) submissions, and aspects of Design History Files, as well as management of regulatory packs for each territory.
Additionally, the regulatory affairs officer will assist in ensuring the correct functioning of related systems within the Quality System such as Medical Device Reporting, Post Market Surveillance(PMS), post market clinical follow-up, clinical evaluations and creation of the pre-market clinical strategy for new products.
We are looking for candidates with the following attributes:
- Degree level in engineering or appropriate academic discipline
- Not less than 3 years’ experience in regulation of class II/III medical devices
- Excellent knowledge of MDD/MDR.
- Preferably good knowledge of ISO 13485 and one or more of the following:
- ISO 14971
- MEDDEVs and other guidance documentation
- ISO 62304
- ISO 60601
- ISO 10993
- ISO 11135
- Experience of working with international distributors
- PMS and vigilance management
- Excellent problem-solving communication, and organisational skills
- Excellent written English and report writing ability
- Results focused with ability to work on own initiative
- Computer literate
- Driven to succeed
For further information or to apply please contact our Human Resources Director, email@example.com
Please note: This role is not being resourced through recruitment agencies. No calls please.
The following Company benefits apply:
- 25 days holiday, with the potential to purchase an extra 5 days each year
- Permanent health insurance
- Childcare vouchers
- Share option scheme