Our people are ambitious and humble , believing in what they do and convinced that our purpose is shaping a world of trust . With responsibility and openness , they daily serve our 400.000 clients in 140 countries, to bettering society. Across all our businesses and countries, each one of our people leaves their mark in shaping society .

We believe that leaving a mark is a true challenge and opportunity for every one of us.

We believe that leaving a mark is a sign of trust and impact.

We believe that leaving a mark is a bond with the future.

We believe that leaving a mark is proof of growth and development.

Being part of the BV family, is more than just working, it’s being convinced that you will leave your mark... in shaping a world of Trust .

Business Duties

• Supports the audit delivery in medical device Sector (ISO 13485, MDD/MDR CE Marking)

• Supports the process of obtaining and maintaining the relevant approvals/accreditations.

• Develops procedures for product delivery, which satisfy appropriate requirements, (e.g. accreditation requirements)

• Helps define criteria for the control and development of the Competences Centres, which deliver the product.

• Provides product support to the network and/or coordinate projects related to product development.

• Maintains an in-depth knowledge of the product and related standards and requirements, in order to provide credible and efficient support.

• Promotes existing products/services.

• Provides trainings to technical requirements and details MDR requirements.

• Regularly meets clients, competitors and stakeholders, to understand and summarize clients’ needs and anticipate evolutions.

• Cooperates on the definition & implementation of global marketing initiatives.

• Supports the accreditations activities of BVC worldwide and performs any other activities, as instructed by their line manager.

People Development

• Lead through example by tireless learning

• Engage with Team member and create “One Team” culture

• Acquire talents from various channel to enhance existing service and to expand service scope

• Provide with necessary/relevant training to potential talent to enhance capability and upgrade job skillset and contribute to drive result

• Develop successor plan to narrow down the position vacancy and smooth transition

• Organize efficient team with right position with its clear role & responsibility

Report

• Report to BU Manager and dotted line report to Region and GBL

Qualification:

• Major: Technical scientific master’s degree (e.g.: bioengineering, clinical engineering, chemistry, biology, computer science, electrical engineering, electronics, mechanics, physics, medicine, pharmacy, biotechnology, engineering, mathematics, natural sciences)

• 4 years of professional experience in the field of health care products or related activities, such as manufacturing, research or auditing; of them 2 years of experience in the design, manufacture, testing or professional use of the medical devices or technology to be assessed or in fields connected with the technical-scientific aspects to be assessed.

• In the event that the experience was acquired only with activities carried out in a CAB, at least five FT assessments are required in the previous two years also in relation to Directive 93/42.

• Working Experience accepted as follows;

• design, research and development, manufacture, quality control and regulation in the field of health products

or

• Study of the technology of a medical device and its application;

or

• performing tests on a medical device in accordance with national or international standard

or

• performing performance tests, clinical evaluation or clinical testing of a medical device .

or

• Continuing activity for at least 3 years of auditing in a definite manufacturingtechnology for MDs

or

• technical support activities for the examination of audit reports and for the development of schema documents - for at least two continuous years - at the certification / notified body for medical devices or accredited by ISO 13485

• In-depth knowledge and Completion of course Directive 93/42/EEC , REG (EU) 2017/745 and of related binding legislation and knowledge of other guidelines related with Directive 93/42/EEC , REG (EU) 2017/745

• Successful completion of specific course (40 hours for ISO 9001; upgrade course for ISO 13485)

• Completion of course related with risk management (rif. ISO 14971)

• Completion of course the principles of clinical evaluation

Join an inclusive, flexible and diverse company where you can thrive while contributing to positively transforming the world we live in.

#ShapingaWorldofTrust #leaveyourmark