OBS! Ansökningsperioden för denna annonsen har
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Arbetsbeskrivning
DNV is the independent expert in assurance and risk management, operating in more than 100 countries. Through our broad experience and deep expertise we advance safety and sustainable performance, set industry benchmarks, and inspire and invent solutions.
We are one of the world’s leading certification, assurance and risk management providers. Whether certifying a company’s management system or products, providing training, or assessing supply chains, and digital assets, we enable customers and stakeholders to make critical decisions with confidence. We are committed to support our customers to transition and realize their long-term strategic goals sustainably, and collectively contributing to the UN Sustainable Development Goals.
DNV Product Assurance AS is an accredited Certification Body for ISO 13485, a recognized auditing organization under MDSAP and approved Notified Body for Medical Devices Regulation. We provide global market access by certifying the safety and quality of products and systems to international safety and quality standards and regulations. Our high professional standards and our sustainable approach guarantee you a forward-thinking work environment, within an organization that invests in its employees, and is committed to providing you with continued development.
Position Description
The Training & Competence Specialist has full responsibility and accountability to ensure a seamless and efficient training and competence process for all Medical resources, globally.
The successful candidate will put together a seamless training process to ensure new recruits are qualified in a timely and efficient manner, whilst also ensuring all employees in the medical hub maintain existing codes across areas such as ISO 13485, MDD 93/42/EEC, MDR 745/2017, MDSAP, IVDR and Clinical standards.
Another key part of the role is the authorization/approval of all medical employees for their roles and codes within given timelines and releasing these employees into the regions for medical projects.
The role reports to the Head of Sales and Operations, is full-time and not location-specific, though Europe would be a preference.
Competency Requirements:
The successful candidate must have proven knowledge and experience in all of the following:
European Union devices legislation and relevant guidance documents
the conformity assessment procedures provided for in the MDR
a broad base of knowledge of device technologies and the design and manufacture of devices
training relevant to that of personnel involved in conformity assessment activities in relation to devices
minimum 3 years’ experience in conformity assessments under the MDR or previously applicable law within a notified body.
Personal Skills:
Demonstrated experience in designing, developing and implementing a robust and efficient training and competence program
Excellent project management skills
Excellent interpersonal and communication skills
Experience of working under own initiative and in planning and prioritizing workloads
Excellent stakeholder management skills
Strong written and verbal English communication skills
For more information about the role, please contact Cecilie Gudesen Torp, Managing Director at +47 41616969.
If you're interested in applying, please submit your resume and cover letter in English.
Please be informed you may be requested to provide DNV with additional documents for a background check.
You will be hired on local conditions.
Interviews will be held on an ongoing basis.
Union Representative's contact information:
Sveriges Ingenjörer: Anna Berglund@dnv.com
Unionen: Maria Bylund@dnv.com
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