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Regulatory Affairs Officer

Job Title: Regulatory Affairs Officer
Contract Type: Contract
Location: Leicestershire, England
Industry:
Salary: Up to £30.00 per hour
Start Date: April 2018
Reference: 71345-PHARM-JHY_1522077745
Contact Name: James Harvey
Contact Email: James.Harvey@volt.eu.com
Job Published: March 26, 2018 16:22

Job Description

Job title: Regulatory Affairs Officer
Job type: 12 month maternity cover contract
Location: Leicestershire, East Midlands, UK
Salary: £25.00 - 30.00/hour

Summary:

- My client is a global technology firm with a successful and highly-regarded
healthcare division
- They are looking to add to their team a motivated and experienced Regulatory
Affairs Officer with experience of drugs and devices

Role purpose:

- To support the development and commercialisation of a range of pharmaceutical
drug and medical device products
- Provide regulatory advice on new product development and product change
- Take responsibility for estimation and monitoring of regulatory resource
requirements

Required skills & experience:

- Strong regulatory experience including global drug and device registration
- Experience in CE marking, including writing Technical Dossiers for complex
medical devices which use electronics and software/firmware
- Experience in Registration of Drug/Device combination products including device
clearance
- Global experience in App development and 510(K) applications
- Bachelors' degree in Science

Interpersonal skills:

- Proven project planning skills
- Strong written and verbal communication skills
- Strong interpersonal and team skills with experience of dealing with external
customers
- Strategic thinker who can deliver regulatory solutions
- Easily adaptive to change and new circumstances
- Able to handle multiple and complex tasks and be comfortable getting involved in
detailed regulatory work as well as understand the bigger picture
- Capable of understanding the business needs and priorities and translating these
into appropriate regulatory actions
- Strong IT skills

Please apply online.

For more information please contact James Harvey at Volt Europe on 01737 236 706