Regulatory & Risk Manager - Midlands £60k, West Midlands – Jobs24.co.uk
/
/
/
Regulatory & Risk Manager - Midlands £60k

Science & Pharma Jobs in West Midlands

Finding Science & Pharma jobs in West Midlands is easy with jobs24. We work with local employers and recruitment agencies to help you find Science & Pharma jobs quickly and simply so logon to jobs24 today to see the best range of local jobs in West Midlands.

Add to saved

Regulatory & Risk Manager - Midlands £60k

Published
11-01-2017
Job ad details
Published
11-01-2017
Expires
25-01-2017
Job ID
LJA-40662697
Jobtype
Full-time
Permanent
Salary level
£60,000 - £70,000  per year
Job sector
Science & Pharma

A Medical Device client I am currently working with is looking for a Regulatory and Risk Manager on a permanent basis for their site based in the Midlands. Key Responsibilities To drive the company to deliver sufficient depth of evidence to demonstrate regulatory compliance. To drive the vigilance processes (PMS feedback, regulatory changes, adverse events, competitor information, literature searches) required in Europe, US and other relevant markets. To deliver PMS report, Vigilance Report and clinical evaluation report in line with the relevant plans. To define the appropriate regulatory pathways for entry into global markets and support other members of the company in understanding the regulatory pathways. To provide advice on possible approaches to de-risking and accelerating project completion. To provide advice on approaches taken by other companies for comparable products in satisfying regulatory requirements. To provide risk assurance support into the design and development process, to assure risk consideration and acceptability as ALAP throughout the product development lifecycle. To provide managerial leadership for RA team members, ensuring that there is a common agreement on strategy, priorities and deadlines, and to maintain a strong understanding of delivery against plans and targets. Requirements/Qualifications Strong understanding of regulatory standards and their implementation in a Medical Device framework i.e. Medical Device Directive (93/42EEC), ISO 13485, ISO 14971, IEC 60601,IEC 62366, IEC 62304, 21 CFR 820,21CFR 807, 21 CFR 11. Experience in working with PEMS (Programmable Electrical Medical Systems) or equivalent high-integrity software-intensive systems i.e. complex devices requiring multidisciplinary development effort (mechanical engineering, software, electronics, system integration, pneumatics, fluid mechanics, etc.). Experience of working with risk management, regulatory requirements, document management systems, issue management systems. Trained in application of IS014971. Ability to work with external bodies. Good team player and effective communicator. Flexible approach to hours. Ability to operate at strategic and operational levels. Ability to identify strategic and operational issues and develop plans to address. Ability to lead; demonstrating assertiveness, team building and management skills. Attention to detail. Effective communicator. Articulate, persuasive personality. Extensive experience working in product development & delivery. Sound technical knowledge of product base and application. Degree or equivalent experience in appropriate subjects. Vacancy Summary: Job type: Permanent Location:Midlands Rate: £60,000 If you are interested in this role or know anyone who might be please get in touch with an up to date CV and I'll be in touch shortly to discuss setting up an interview

Apply now

You have not attached any documents to your application. Click the 'OK' button below to send your application anyway or click the 'Cancel' button and attach documents before submitting your application again

Share this job

Share this job

Job ad details
Published
11-01-2017
Expires
25-01-2017
Job ID
LJA-40662697
Jobtype
Full-time
Permanent
Salary level
£60,000 - £70,000  per year
Job sector
Science & Pharma
Add to saved