Technical Planning Specialist
Intertek Semko Notified Body / Sjukhusteknikerjobb / Stockholm
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Vi hjälper våra kunder att se till att deras processer, produkter och system är säkra och håller den kvalitet som både myndigheter och kunder världen över förväntar sig. Det gör våra 42 000 medarbetare världen över genom att inspektera laster och fabriker, testa och certifiera allt från leksaker till medicinteknik, granska underleverantörer, certifiera ledningssystem, analysera livsmedel, oljeprodukter och kemikalier och utvärdera batterilösningar för elfordon. Bland mycket annat. Vi gör världen lite säkrare, helt enkelt!
Bringing quality and safety to life
About Us
Intertek is the trusted service provider to many of the world's leading brands, companies and governments, and has earned a reputation for accuracy, reliability, integrity, and technical competence.
Our Assurance, Testing, Inspection and Certification services take us into nearly every field, from textiles, toys and electronics, to building, heating, pharmaceuticals, petroleum, food, cargo scanning and medical devices.
In a world where a company's success depends on its reputation for quality, safety, and socially responsible products and processes, Intertek employees make a difference.
Join the team at Intertek and work with some of the best, brightest, and most inspiring people in the assurance, testing, inspection, and certification industry.
Key purpose of the role
In the exciting journey towards the Medical Device Regulation (MDR) and with recent organisational changes to strengthen the team, we are looking for a Technical Planning Specialist to support our journey towards a robust and high performing Notified Body. Reporting to the Technical Planning Manager and based in Stockholm, Sweden or Milton Keynes, UK the role is full time and includes:
Responsibilities to ensure the Notified Body activities related to technical planning are performed accurately and timely. This role also has responsibility to contribute to the Notified Body's Planning team for compliance against the following requirements;
• EU Medical Device Directives (e.g. 93/42/EEC)
• REGULATION (EU) 2017/745 of the European Parliament and of the Council on medical devices.
Further the role will also more specific include:
• Assist in developing, maintaining and improving processes, procedures, forms and registers to enable the technical planning to run effectively and efficiently.
• Responsible for Change management implementation in relation to our customers
• Management of Change Notice database
• Evaluate and validate Client Information
• Review revisions of contracts for existing clients on a regular basis
• Manage incoming technical enquiries, as received by the coordinator responsible for the specific inbox.
• Review and approve Addition of products to scope or pass them on to TD assessors, Clinical or CA
• Set up cycles for Unannounced audits
• Monitor the regulatory environment related to NB designation
• Monitoring of Vigilance reporting from our customers
• Ensure that initial technical sampling is extended to include appropriate clinical sampling in collaboration with the clinical team and monitor adherence to the sampling rationale
• Management of the Technical File Sampling plans to ensure the Technical File Sampling Plans are appropriate and based on the clinical evaluation and risks related to the products.
• Management of Sampling database
Competencies, personal attributes and skills
The role holder should possess either an appropriate degree, college degree or other qualifications and/or experience in either Health Science, Engineering or Quality/Regulatory disciplines related to the Medical Device industry sectors. Has preferably at least 3 years' experience of either working in the medical device industry. Has knowledge of the EU Medical Device Directives and Regulations and Quality Management Systems. Has a keen eye for detail and is focussed on delivering accurate and robust results within agreed timeframes. Operates ethically with the highest degree of professional integrity
Fluent in English and preferably in Swedish, written and spoken.
Contact:
Technical Planning Manager, Pontus Gedda +46 709 609100
pontus.gedda@intertek.comVaraktighet, arbetstid
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Publiceringsdatum2018-09-21ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-10-21
Klicka på denna länk för att göra din ansökanFöretagIntertek Semko Notified Body
AdressIntertek Semko Notified Body
Torshamnsgatan 43
16440 Kista
KontorsadressTorshamnsgatan 43
Jobbnummer 4360437
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