Senior Regulatory Affairs Engineer

Confirmation of Vacancy
Job Title: Senior Regulatory Affairs Engineer

JOB DESCRIPTION

JOB TITLE: Senior Regulatory Affairs Engineer

DEPARTMENT: Quality & Regulatory Affairs

RESPONSIBLE TO: Regulatory & Product Development Senior Manager

Overall purpose: To work as part of the Regulatory Affairs team to ensure the Company achieves its quality & regulatory objectives. To assist the Regulatory & Product Development Senior Manager by providing day-to-day guidance to other members of staff as required. Keeping the Regulatory & Product Development Senior Manager informed of critical issues requiring decisions.

Main duties & responsibilities:

1. Undertake regulatory affairs activities for new product introductions to ensure the appropriate legal compliance of medical device products. Construction and on-going maintenance of Technical Files in accordance with the Medical Devices Directive 93/42/EEC as amended.

2. Proactively providing regulatory advice, guidance, and expertise to new product development project team(s) including identifying and mitigating regulatory risk. Leading regulatory approval teams to ensure project objectives are met

3. Work with overseas distributors and internal departments to register the Company’s products in international markets. Development of the necessary procedures to ensure international registrations are completed successfully and on time. Keeping abreast of relevant international legislation, guidelines and customer practices.

4. Directing the Regulatory Affairs Officer, assignment and monitoring of work carried out by the individual. Providing advice and assistance on regulatory matters as required.

5. Participate in the internal audit programmes to ensure maintenance of the Company’s regulatory and quality systems. Work with internal departments to contain and correct problems. Where nonconformities are identified, these shall be resolved with the appropriate member of staff in a timely manner.

Knowledge & skills required

1. The individual needs to be innovative and creative with regard to identifying solutions to problems and also improving existing systems and processes.
2. Ability to provide clear, concise and comprehensive verbal and written reports to all levels of within the Company. Ability to liaise and negotiate with others in the pursuit of goals. Must be able to work with others, providing support and constructive ideas in addressing problems.
3. A knowledge of regulatory frameworks locally and overseas, excellent planning and organisational skills, are all highly recommended as is the ability to converse confidently with both internal and external parties.
4. Self-motivated and well organised flexible, adaptable with excellent planning and organisational skills. Computer literate

Hours: Monday to Thursday 07:30 to 16:00 and Friday 07:30 to 13:00
Salary: to £45,600Permanent Worthing Ref: 3488TPP