Senior RA Specialist

Job Ref: J29278
Sector: Engineering
Sub-sector: Medical Devices
Job Type: Permanent
Date Added: 04 December 2018
  • Deeside, Flintshire, Wales, UK UK
  • £40,000 - £50,000 per Annum
  • Laith Mustafa
  • 0161 868 2231

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Senior Regulatory Affairs Specialist- Deeside- 40-48k -Temp to Perm- Maternity CoverOur client is a developer, manufacturer and marketer of innovative medical products focused on therapies for the management of chronic conditions. This role is based around continence, critical care and infusion devices used in the treatment of diabetes and other conditions. Job SummaryThis role requires the person to operate as a medical device regulatory resource for the Company and effectively deputise for the Regulatory Affairs Manager, as necessary.The person will be responsible for the management of global and regional regulatory projects, including, but not exclusively, new product development, product life cycle and regulatory processes. There will be a focus on developing strategies and document preparation for products marketed in the US and EU.Duties and Responsibilities* Creation, development and maintenance of high quality regulatory compliant documentation, especially Class 1, Class IIa and Class IIb products for EU market and Class I & II/Unclassified products for the US market.* For medical device products under development, liaise with Project Development teams to ensure regional RA requirements are included in the project plan and prepare the pre-marketing documentation (e.g. for CE marking and 510k) according to the agreed timeline and achieve regulatory clearance* Builds relationships and negotiates with relevant regulatory bodies on matters related to compliance of existing products and products undergoing development* Creates new and innovative ways of doing things, demonstrates flexibility, open-mindedness, and adaptability to a rapidly changing environment.* To assist with global regulatory processes, such as Change Control, GMDN, etc. Travel Requirements NMT 5% of work time. There may be some business related travel associated with this role dependent on project and / or local market and UK travel associated with this role because some team members are home based and face-to-face contact with line manager and peers may be required. Focus on US regulatory matters may require US travel.Attendance of relevant training and development events would be required.Some destinations may involve overnight stay(s).Requirements:* Demonstrated Regulatory experience in medical devices * Experience dealing directly with Notified Bodies, Competent Authorities, and US FDA desirable* Hands on experience of creating documentation compliant with EC Medical Devices Directive 93/42/EEC and FDA CFR 820* Knowledge of compliance with key international standards such as ISO 13485, ISO 14971 * Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercial

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

03/01/2019 09:46:18
GBP 40000.00 40000.00.