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Data Analyst - Medical Devices - EU-MDR - Pharmaceuticals
Eingestellt von Elevate Direct
Gesuchte Skills: Support
Projektbeschreibung
DATA ANALYST/DIEGEM, BELGIUM/10 MONTHS CONTRACT/UP TO 28 EUR (PER HOUR)
Under the new Medical Device Regulation, medical device vigilance requirements are changing. The role of EU-MDR analyst is to support the Global Surgery EU MDR Business Lead in ensuring ETHICON and Biosense Wester Customer Quality Vigilance team's readiness for MDR implementation with regards to Vigilance and Post Market Surveillance.
DUTIES & RESPONSIBILITIES
The EU MDR Analyst, based in the Biosense Webster European Headquarters in Belgium, will under minimal supervision and in accordance with all applicable national laws/regulations and Corporate Johnson & Johnson, procedures and guidelines
- Collect, organize and document product and process specific information from within the various franchises of Global Surgery to facilitate update of enterprise complaint management system.
- Collaborate with enterprise complaint management system team and data backbone team to define system requirements and test functionalities
- Align and collaborate with Global Orthopaedics counterpart
- Collaborate with European and US based teams within the various franchises of Global Surgery to ensure project timelines are met
- Update Internal Procedures as required
- Support EU-MDR Business Lead as needed
NON TECHNICAL SKILLS
- BS degree with experience within a regulated medical device/clinical environment preferred
- Excellent analytical and communication skills are essential
- Demonstrated computer literacy is required.
- Fluent in English written and oral
- Ability to be detail oriented with background adequate to deal with Quality System concepts related to Medical Device regulations and SOPs.
- Experience with MDD regulations and ISO 13485 would be an advantage, with experience in Complaint management a plus
- Familiarity with or ability to become familiar with clinical and risk management terminology
- Ability to manage large data sets
- Ability to read and synthesize technical material and to prepare clear and concise written documents.
- Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff is a must
- Goal orientated with the ability to challenge the status quo to ensure process improvement
JOHNSON & JOHNSON IS AN AMERICAN MULTINATIONAL MEDICAL DEVICES, PHARMACEUTICAL AND CONSUMER PACKAGED GOODS MANUFACTURER FOUNDED IN 1886.
IF YOU MATCH THESE REQUIREMENTS, PLEASE APPLY IN THE NORMAL WAY. ELEVATE WILL SEND YOU AN EMAIL, PLEASE OPEN, CLICK AND ACTION THAT EMAIL AND YOUR APPLICATION WILL BE VISIBLE TO THE HIRING ORGANISATION DIRECTLY.
Under the new Medical Device Regulation, medical device vigilance requirements are changing. The role of EU-MDR analyst is to support the Global Surgery EU MDR Business Lead in ensuring ETHICON and Biosense Wester Customer Quality Vigilance team's readiness for MDR implementation with regards to Vigilance and Post Market Surveillance.
DUTIES & RESPONSIBILITIES
The EU MDR Analyst, based in the Biosense Webster European Headquarters in Belgium, will under minimal supervision and in accordance with all applicable national laws/regulations and Corporate Johnson & Johnson, procedures and guidelines
- Collect, organize and document product and process specific information from within the various franchises of Global Surgery to facilitate update of enterprise complaint management system.
- Collaborate with enterprise complaint management system team and data backbone team to define system requirements and test functionalities
- Align and collaborate with Global Orthopaedics counterpart
- Collaborate with European and US based teams within the various franchises of Global Surgery to ensure project timelines are met
- Update Internal Procedures as required
- Support EU-MDR Business Lead as needed
NON TECHNICAL SKILLS
- BS degree with experience within a regulated medical device/clinical environment preferred
- Excellent analytical and communication skills are essential
- Demonstrated computer literacy is required.
- Fluent in English written and oral
- Ability to be detail oriented with background adequate to deal with Quality System concepts related to Medical Device regulations and SOPs.
- Experience with MDD regulations and ISO 13485 would be an advantage, with experience in Complaint management a plus
- Familiarity with or ability to become familiar with clinical and risk management terminology
- Ability to manage large data sets
- Ability to read and synthesize technical material and to prepare clear and concise written documents.
- Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff is a must
- Goal orientated with the ability to challenge the status quo to ensure process improvement
JOHNSON & JOHNSON IS AN AMERICAN MULTINATIONAL MEDICAL DEVICES, PHARMACEUTICAL AND CONSUMER PACKAGED GOODS MANUFACTURER FOUNDED IN 1886.
IF YOU MATCH THESE REQUIREMENTS, PLEASE APPLY IN THE NORMAL WAY. ELEVATE WILL SEND YOU AN EMAIL, PLEASE OPEN, CLICK AND ACTION THAT EMAIL AND YOUR APPLICATION WILL BE VISIBLE TO THE HIRING ORGANISATION DIRECTLY.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges