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QA/RA Specialist Medical Device
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Engineering, Support
Projektbeschreibung
QA/RA SPECIALIST
Our client, a global Medical Device manufacturing organisation, is currently looking for a QA/RA Specialist to support them during a new QA improvement drive within their surgical tools division.
The role is to work on the full life cycle of products from throughout development to submission of regulatory files for manufacturing approval.
LOCATION: Switzerland Germany
DURATION: 9 months contract
PRINCIPAL DUTIES AND RESPONSIBILITIES
- Manage QA compliance for products for application and submission to accredited laboratories; reviews of requirements and implementation.
- Manage recognized certification processes for products including dossier preparation, submission to accredited agencies, reviews of application and implementation.
- Manage instruction manuals (IFUs) creation and revision including translations, verifications and publishing processes.
- Responsible of the application of the Risk Management process for existing and new products to insure compliance of the RMF.
- Provide regulatory direction to development project teams as a core team member and develop regulatory strategy for new products.
- Review proposed product changes for impact on regulatory status of the product.
- Interpret and applies Medical Devices Directive, RoHS EU directives, and FDA regulations to business practices and provide regulatory input, advice and guidance to the organization.
- Manage change notification to notify body process, including authoring and publishing electronic submissions.
- Maintain the CE mark Tech File updated in accordance with products specification creation and changes.
EXPECTED AREAS OF COMPETENCE
- Understand the overall business environment including the orthopaedic industry.
- Mastery of relevant regulations, ability to stay abreast of regulations pertinent to medical devices.
- Able to identify and assess business risks for a given regulatory strategy.
- Ability to diplomatically discuss sensitive information with consultants, suppliers, or customers.
- Ability to apply GMP.
- Present and discuss clinical, design or manufacturing, issues with internal and external personnel.
EDUCATION/EXPERIENCE REQUIREMENTS
- Bachelor's Degree (4 year university degree) or equivalent.
- Degree or background in life sciences, technical (engineering) or related field.
- Regulatory Affairs Certification (U.S. or EU) preferred.
- The background of the successful candidate will include the medical device experience, and preferably orthopaedics experience.
Our client, a global Medical Device manufacturing organisation, is currently looking for a QA/RA Specialist to support them during a new QA improvement drive within their surgical tools division.
The role is to work on the full life cycle of products from throughout development to submission of regulatory files for manufacturing approval.
LOCATION: Switzerland Germany
DURATION: 9 months contract
PRINCIPAL DUTIES AND RESPONSIBILITIES
- Manage QA compliance for products for application and submission to accredited laboratories; reviews of requirements and implementation.
- Manage recognized certification processes for products including dossier preparation, submission to accredited agencies, reviews of application and implementation.
- Manage instruction manuals (IFUs) creation and revision including translations, verifications and publishing processes.
- Responsible of the application of the Risk Management process for existing and new products to insure compliance of the RMF.
- Provide regulatory direction to development project teams as a core team member and develop regulatory strategy for new products.
- Review proposed product changes for impact on regulatory status of the product.
- Interpret and applies Medical Devices Directive, RoHS EU directives, and FDA regulations to business practices and provide regulatory input, advice and guidance to the organization.
- Manage change notification to notify body process, including authoring and publishing electronic submissions.
- Maintain the CE mark Tech File updated in accordance with products specification creation and changes.
EXPECTED AREAS OF COMPETENCE
- Understand the overall business environment including the orthopaedic industry.
- Mastery of relevant regulations, ability to stay abreast of regulations pertinent to medical devices.
- Able to identify and assess business risks for a given regulatory strategy.
- Ability to diplomatically discuss sensitive information with consultants, suppliers, or customers.
- Ability to apply GMP.
- Present and discuss clinical, design or manufacturing, issues with internal and external personnel.
EDUCATION/EXPERIENCE REQUIREMENTS
- Bachelor's Degree (4 year university degree) or equivalent.
- Degree or background in life sciences, technical (engineering) or related field.
- Regulatory Affairs Certification (U.S. or EU) preferred.
- The background of the successful candidate will include the medical device experience, and preferably orthopaedics experience.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges