Training & Competence Specialist
DNV GL USA, INC.

Job Info

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Local Unit & 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 into the Head of Sales and Operations, is full time and not location specific, though Europe would be a preference.
Position Qualifications

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
• adequate 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

Qualification:

The Training and Competence Specialist should hold a diploma or degree from a university or technical college in medicine, science, or engineering (educational requirement). Examples include but are not limited to the following:

• Biology
• Microbiology
• Chemistry
• Biochemistry
• Computer hardware and software technology
• Material sciences
• Engineering - electrical, mechanical, biomedical, clinical, bioengineering,
• Human physiology
• Medicine
• Pharmacy
• Physics and biophysics

The Training and Competence Specialist shall demonstrate at least four years of relevant full-time experience.

The Training and Competence Specialist shall preferably demonstrate the experience and skills of a Lead Auditor and have a broad base of knowledge of device technologies and the design and manufacture of devices. Pre-requisite Competence Requirements.

We Offer

• A strong company culture with an emphasis on competence development
• Great colleagues who value teamwork and support
• Attractive total compensation package
• International working environment
• Interesting and challenging projects, both national and international
• Be part of a world-leading company that has a global reach with more than 12 000 employees around to world and is headquartered in Norway
• The possibility to grow and develop your competencies and ambitions within DNV

Company & Business Area Description

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.

Equal Opportunity Statement

DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity!

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