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Kortrijk, BE

Date:  Sep 22, 2021
Job ID:  696

Healthcare Compliance Director

Barco designs technology that makes everyday life a little better. Seeing beyond the image, we develop sight, sound, and sharing solutions to help you work together, share insights, and wow audiences. Our focus is on three core markets: Enterprise (from meeting and control rooms to corporate spaces), Healthcare (from the radiology department to the operating room), and Entertainment (from movie theaters to live events and attractions). With a team of over 3,300 employees, located all around the globe, we realized sales of 770.01 million euro in 2020. 

The Healthcare Compliance Director ensures that all Barco teams worldwide that support the Healthcare business are complying with the applicable healthcare industry regulations. If product & process compliance, regulatory affairs and data protection are your areas of expertise, this new position could be your next challenge!  

The primary responsibilities of the Compliance Director Healthcare are:
•    You develop and implement, in close collaboration with Barco’s Global Compliance Manager, Barco’s worldwide compliance programs specifically for its activities in the Healthcare industry; coordinating efforts with the different teams to ensure implementation of the industry specific regulations (including HIPAA, Sunshine Act, GDPR, ..., and product compliance to FDA, MDR, Fagg and relevant local country regulations) and standards (e.g. Cocir Code of Conduct). You will also work closely with the legal team for interpretation of healthcare specific regulations.
•    You implement an audit program to assess the compliance program’s effectiveness, identify areas of risks and develop improvement plans to address those risk. You cover full end-to-end activities across Barco with respect to the Healthcare products (including supporting production, procurement, software development, sales and marketing teams etc.)
•    You set up awareness and training programs on healthcare compliance obligations for the different stakeholders, in close collaboration with Barco University
•    You manage the global Healthcare Regulatory affairs department and local regulatory affairs team including people and budget
•    You ensure compliance to medical device regulations for the Healthcare products in the applicable countries
•    You coordinate and plan pre-market activities during new product development, product registration at product release and post-market surveillance after product release
•    You develop a regulatory intelligence program to follow up and implement regulatory changes
•    You coordinate product recalls as needed; support external audits and inspections (eg by FDA)
•    You organize appropriate risk management frameworks, and maintain a network of clinical specialists for advice
•    You oversee and monitor ongoing privacy and data protection compliance activities, in close collaboration with the Data Protection Officer; acting as HIPAA Privacy Officer and provide guidance on HIPAA requirements. 
•    You build and maintain a network of key contacts at relevant regulatory bodies
•    You monitor and approve communications with worldwide regulatory bodies (incl. notices of breaches and disclosures)
•    You act as the primary point of contact for healthcare regulatory compliance topics in respect of healthcare management team and corporate staff functions such as Quality, Legal, Internal Audit, etc.
•    You report to the Senior VP of the Healthcare division


Your profile:
•    You hold a masters degree in law, or in a technical field, or an equivalent combination of experience and education
•    You have experience in managing compliance regulations , ideally in a healthcare or medical devices environment. Having experience in another highly regulated industry can be considered as well.
•    Having active knowledge about medical device regulatory requirements in the different countries (MDD, FDA, Canada Health, …) is considered an asset. 
•    You have good verbal and written communication skills, active listening skills, influencing skills 
•    You thrive in a changing, dynamic environment where you are actively steering & shaping the compliance culture 
•    You are a leader of people who values teamplay and is able to motivate and coach your team and your stakeholders you work closely with.
•    Your analytical skills enable you to make sound decisions.
•    You fulfil your role with integrity & ethics at all times.
•    You are open to a limited amount of business travel