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Job Details

Medical Device - Regulatory Affairs Specialist

Company: Regulatory Professionals
Location: Hampshire
Reference: J32099
Closing Date: 23 Mar 18
Type: Contract
Salary (£): Negotiable
Benefits: Competitive

Job Summary:

Medical Device - Regulatory Affairs Specialist An established medical device organisation seeks an experienced Regulatory Affairs Specialist to join their ever growing team of individuals on a 12 month contract basis.

Requirements:

Medical Device - Regulatory Affairs Specialist
12 month contract
*Urgent Requirement*
Hampshire based

An established medical device organisation seeks an experienced Regulatory Affairs Specialist to join their ever growing team of individuals on a 12 month contract basis. This fantastic opportunity if ideal if you are looking to expand your Regulatory experience within the medical device industry.

The ideal candidate with have 5 years experience as a Regulatory Affairs Manager/ Specialist and must have experience with active medical devices. Experience with non evasive, active medical devices (electronic /software) is advantageous.
Responsibilities include;
- Identifying, monitoring and analysing new and existing medical device legislation
- Communicating new regulatory requirements and risks to actively collaborate with the design and manufacturing teams
-Maintenance of technical files
-Manage regulatory submissions to global territories including US and Far East
-Write new submissions for global territories
-Liaise with regulatory bodies

Candidate Requirement include:
- At least 5 years' experience within a regulatory affairs position working on active devices
-Experience of electronic medical devices - IEC60601
-Experience of risk management within medical device IEC14971
-Experience of IEC63366 / IEC62304 is advantageous
-Experience of FDA 510K product registration is high desired
-Good understanding of complaints and vigilance requirements for US / Europe
-Excellent communication, presentation and influencing skills
-Experience of Japanese / Chinese submissions preferable

London, North London, Herts, Hertfordshire, Essex, Middlesex, Bucks, Beds, Berkshire, hants, berks, surrey, m3 corridor, 13485, 510(k), fda, submissions, pms, erc, pmcf, apac, eu, iso, iec, ansi, meddev, mdd, capa, devices, device, med tech, reg, ra, qa, regs, electronic, software

Apply for this job: Medical Device - Regulatory Affairs Specialist

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
RG1 1LG
England
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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