Active Devices Expert - Medical Devices - Austria
Salary: 40,000 - 60,000
Conditions: Full Time
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 Technical Lead, 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.
Requirement: 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.
- Sterility Aseptic Sterile Manufacturing
- Electro-medical devices for diagnostic or therapeutic purposes.
Function of the position:
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 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 (average 6-8 weeks annually) to represent them 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.
60601 / 60602 / ACTIVE DEVICES / ELECTRICAL / ELECTRONICS / ELECTRO-MECHANICAL / ELECTROMECHANICAL / ELECTRO MECHANICAL / QA / QUALITY ASSURANCE / ISO13485 / AUDITING / AUDITORS / REGULATORY AFFAIRS / R&D / MEDICAL DEVICES / RESEARCH / DEVELOPMENT / MANUFACTURING / ENGINEERING / VASCULAR / CERTIFICATION / QMS / RESEARCH / PRODUCT DEVELOPMENT / NPD / NPI / MANUFACTURING / HEALTHCARE / CLASS 1 / CLASS 2 / CLASS 3 / CLASS 3A / CLASS 3B / CLASS I / CLASS II / CLASS III / PROCESS ENGINEER / PRODUCTION / NPD / PHARMA / PHARMACEUTICALS / R&D MANAGER / RESEARCH MANAGER / DEVELOPMENT MANAGER / HEAD OF R&D / RESEARCH / DEVELOPMENT / MEDICAL DEVICES / STERILES / SURGICAL / ELECTRO MEDICAL / ELECTRO-MECHANICAL / ORTHOPEADIC / DENTAL / OPHTHALMIC / SOFT TISSUE / VASCULAR / IMPLANTS / IMPLANTABLES / WOUND CARE / WOUNDCARE / CARDIOVASCUALR / MEDICAL DEVICES / ELECTRO SURGICAL / SURGICAL DEVICES / GERMANY / EUROPE / BELGIUM / SWITZERLAND / FRANCE / BENELUX / "GERMAN","FRANKFURT","DUSSELDORF","MANNHEIM","BERLIN","MUNICH","HAMBURG","BREMEN","STUTTGARD","DORTMUND","LEIPZIG","HANOVER","NURNBERG", “GERMANY","FRANKFURT","DUSSELDORF","MANNHEIM","BERLIN","MUNICH","HAMBURG","BREMEN","STUTTGARD","DORTMUND","LEIPZIG","HANOVER","NURNBERG", POLAND, BELGIUM, SWITZERLAND, FRANCE, GERMAN, LEVERKUSEN, MAINZ / FREIBURG / WOLFSBURG / HOFFENHEIM / AUGSBURG / ENGLAND / UK