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Job Details

Regulatory Specialist

Company: SRG Clinical
Location: Witney
Reference: J24207
Closing Date: 01 Dec 17
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

My Client a Global Healthcare Organisation has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Affairs Specialist- on an initial 6 Month contract to be based at their offices in Oxfordshire.

Requirements:

The Role:

Responsible for implementing a program to ensure that EU and MENA registrations including Technical Files and Country Specific registration of products are achieved in a timely manner.
Working alongside the UK Regulatory manager to devise and implement strategies, that will ensure products reach the international markets to schedule.

Key Responsibilities:

EMEA Registrations and European Directives: Formulate, develop and implement a program to enable all EMEA registrations to be completed efficiently and to an agreed schedule.
Implement a roll out program for existing products and new launches.
Work with the US team to ensure clear communication of requirements to meet timely worldwide registrations Implement the creation and development of Technical files for both the IVD and Medical Devices Directives.
Sample Requests and Label Copy: Implement a program to ensure efficient scheduling of all sample requests.
Review all baseline (new product) labelling, marketing and training materials for regulatory compliance within EMEA.
Projects: Provide timely guidance and support to project development teams to ensure project development and documentation will meet the regulatory requirements in target countries.
Undertake specific projects as assigned by the line manager to the agreed timescales.

Skills/Experience Required:

Education
Educated to degree level or equivalent preferably in a Scientific or Engineering discipline.

Knowledge
Experienced in regulatory submissions for in vitro diagnostic devices and/or medical devices.

Experience of working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC) and /or the IVD Directive (98/79/EC).


If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

Apply for this job: Regulatory Specialist

Contact Information:

Address:  Head Office
SRG Clinical 9 Devonshire Square London United Kingdom
EC2M 4HP
England
Tel:  +44 (0)203 096 4700
Website:  Visit Our Web Site

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