Regulatory & Risk Manager

Lawrence Harvey


Job ID :

7041


Company Type :

Staffing Firms


Industry :

Science and Research


Education Level :

Master of Science


Address 1 :

United Kingdom,--Birmingham,Birmingham,


Key Skills :

Regulatory Affairs, Medical Device


Salary :

Negotiable


Date Posted :

03 May, 2017



Company Name :

Lawrence Harvey


Location1 :

Birmingham




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

Your key responsibilities will include, but not be limited to

* To drive the company to deliver sufficient depth of evidence to demonstrate regulatory compliance.
* To drive the vigilance processes 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.

Key requirements

* 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.
* Extensive experience working in product development & delivery.
* Sound technical knowledge of product base and application.
* Degree or equivalent experience in appropriate subjects.

If this sounds like you please don'thesitate to apply today!


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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