My Client, a Global Notified Body is seeking IVD Medical Device Experts (Product Specialist/Scheme Managers) in Germany.

Location: Germany, Netherlands, Belgium and Denmark
Position: Permanent
Salary: Negotiable
Industry: Medical Devices, Class I - III

Profile:
Today you are working from home reviewing fatigue test data on a new drug eluting stent design of one of your customers. Tomorrow you audit the manufacturing facilities of a large manufacturer of PTCA catheters in Germany. Next week you present at a medical device regulatory conference in Sweden. As a Notified Body scheme manager, product expert and part of one of our global technology teams, you appreciate the dynamic of working in a mix of regulatory affairs, quality auditing and medical technology innovations. You enjoy an international working environment in a growing team of medical device experts, working with small start-up and large multi-national clients, a bit of travelling and reviewing the latest technologies.

Medical Device Experts
We are a Notified Body for the Medical Device and Active Implantable Medical Device Directives. We provide for our clients worldwide market access to the European Union and other territories by performing conformity assessments of medical devices with respect to safety and performance. We review technical and clinical reports and perform technical and quality audits. We require a number of Medical Device Experts to work on our team to perform these tasks in a competent, transparent, neutral, independent and impartial manner.

We are currently recruiting Medical Device Technical Experts for the following device categories:
· Implantable devices in the orthopaedic, dental, ophthalmic, soft tissue implants, wound care and cardiovascular fields
· Devices that incorporate a medicinal substance: drug – device combinations
· Electro-medical devices for diagnostic or therapeutic purposes.
The Job
Medical Device Experts can work on a number of parts of the regulatory process:
· as a technical expert assessing the manufacturer's technical files and design dossiers;
· as a member of a team auditing a device manufacturer's quality system;
· as a regulatory expert and scheme manager, managing a portfolio of clients with respect to BSI services provides to them.

Team members have overall client management responsibilities and will be competent to review critical design data (including risk analysis, labeling, clinical investigation data and post market surveillance information) and to prepare recommendations for CE certification. They will also participate in the audit activities as a technical expert.

The job will entail some travel to represent BSI and to visit manufacturers to perform the tasks.
Qualifications and Experience
Candidates will have medical device experience within an industrial, academic or clinical background. Their qualifications will reflect a thorough understanding of the technological considerations and manufacturing processes relevant to the field in which they have worked.

It would be an advantage to be familiar with the European medical devices approval process, but full regulatory and auditing training will be provided.

Successful candidates will be motivated to perform detailed investigation of complex technical issues, have a desire to learn new disciplines, are strong communicators, and have strong analytical and organizational skills, and have the presence to make and explain difficult decisions if necessary.
Job Location
The Healthcare Division offices are located in Hemel Hempstead, UK, Darmstadt, Germany and Reston VA, USA. A large number of our team members are home-based and report into one of these hubs. We particularly seek to recruit specialists in Germany, Netherlands, Sweden and Denmark.

To apply please send your cv in MS Word format and salary expectation to darron@adaptresourcing.co.uk

To apply: Send your cv and salary expectation in MS Word format to dericb@adaptresourcing.co.uk