QA RA Manager (f/m)EMEA within R&D in the area of Basel

Lawrence Harvey

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Job ID :

8968


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Other


Address 1 :

Western Europe,--Basel,Basel,


Key Skills :

MDD, ISO 13485, FDA, 510(k), Certified Auditor, Technical background, ISO13485, ISO14791 and US FDA


Salary :

£102089 - £117795 per annum


Date Posted :

05 Oct, 2017



Company Name :

Lawrence Harvey


Location1 :

Basel




Job Category :

Quality Assurance Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

100.00%





Description

QA RA Manager (f/m)EMEA within R&D in the area of Basel

Our client is offering an interesting and varied function in an international and interdisciplinary environment. If you are looking for an modern infrastructure and opportunities to further advance your career as well as attractive compensation package and social benefits please have a look at the description below. Our client is offering a surrounding where you can play a relevant part in a medical network and to further develop a company with an excellent reputation approximately 5000 associates who market the products in more than 100 countries around the world.



Your responsibilities

* Maintenance, training and support of European standards database, by administration of harmonized standards and management of updates
* Creation and maintenance of regulatory product group based requirements for product, documentation and service release
* Leading the organization on all requirements affecting market access (e.g. MDD, 510(k), RoHS) by support on a EMEA level
* Enabling engineering change process including updates of laws, medical requirements and standards
* Reviewing and checking normative requirements for documentation (user guides, sales leaflets, etc.)
* Coordinating requirements for European Test Plan (ETP) by reviewing regulatory issues, to close existing gaps, to enable robust design and consistent test requirements
* Supervising all new product development and sustaining engineering from a regulatory point of view.
*

Qualification:

* Furthermore, you ensure the achievement of the targets and business development objectives. You coach and support the R&D EMEA organization to achieve their results. In addition, you implement appropriate management tools to minimize potential business risks.
* You are part of the QA RA EMEA management team.
* You hold a Master degree in Engineering (or equivalent). You have experience in MDD, ISO13485, ISO14791 and US FDA 820. Furthermore, it would be a plus if you have internal or external qualification as an auditor for Medical Device companies.
* You have proven your ability to implement quality systems in a Medical Device development environment and can train and educate people on quality subjects. You are a self-driven person, who is experienced in leading people by example. You are used to work in a multinational environment and are used to work in a matrix organization. In addition, you are IT literate and fluent in English, any other language would be an asset. You are willing to travel up to 30 % of your time.

SciPro is a people business. We specialise in sourcing, advising and introducing highly skilled life sciences candidates to our client partners across the globe, helping them to achieve their business goals. The art of recruitment isn't solely about filling jobs, it's about matching people with people and creating harmonious and successful working environments. As a leading staffing specialist with offices in the UK, Europe and North America our biggest USP is representing candidates of all levels across Research & Development, Operational Excellence & Performance, Manufacturing Quality, Compliance, Regulation, Data Management, Cost Optimisation and Innovation. We pride ourselves on being able to deliver to almost every requirement in your business, in any location you need it.

Are you motivated, committed and flexible? Do you enjoy taking the initiative and working independently? Do you have a highly developed quality awareness? Do you work conscientiously, and are you resilient to stress?



Then please send your complete application documents by email to Petra Ognjenovic: p.ognjenovic@sciproglobal.de


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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