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Location: 

Kortrijk, BE

Date:  Apr 1, 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 3,600 employees, located all around the globe, we realized sales of 1,082.6 million euro in 2019. 

The Compliance Director Healthcare ensures that all Barco teams worldwide, supporting 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, then this new position could be your next challenge!  


The primary responsibilities of the Compliance Director Healthcare are:
•    You develop and implement, in close concert with Barco’s Global Compliance Manager, Barco’s worldwide compliance program  specifically for its activities in the Healthcare industry and 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).  Working with the legal team for interpretation of healthcare specific regulations.
•    You implement audit program to assess the compliance program’s effectiveness, identify areas of risks and develop improvement plans to address those risks.  Covers full end-to-end activities across Barco with respect to Healthcare products (including supporting teams for production, procurement, software development, sales and marketing, etc.)
•    You setting up awareness and training programs on healthcare compliance obligations for the different stakeholders, in close concert with Barco University
•    You managethe Regulatory affairs department (people and budget)
•    Ensures compliance to medical device regulations for the HC products and in the applicable countries
•    Coordinate and plan pre-market activities during new product development, product registration at product release and post-market surveillance after product release
•    Develop regulatory intelligence program to follow up and implement regulatory changes
•    Coordinates product recalls as needed; supports external audits and inspections (eg by FDA)
•    Organizes appropriate risk management frameworks, and maintains network of clinical specialists for advice
•    You oversee and monitor ongoing privacy and data protection compliance activities, in close concert with the Data Protection Officer; acting as HIPAA Privacy Officer and providing guidance on HIPAA requirements. 
•    You buildand 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 towards the HC management team and corporate staff functions (Quality, Legal, Internal Audit, etc.).
•    You manage the worldwide regulatory team 
•    You report to the Senior VP of the Healthcare division

 

Your profile:
•    You hold a master’s 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. 
•    Your verbal and written communication skills, active listening skills, influencing skills  make you successful in your job
•    If working in a changing, dynamic environment where you are actively steering & shaping the compliance culture gives you energy , then this challenge is right up your alley.  
•    You are a people leader who values teamplay and is able to motivate and coach your team and your stakeholders. For this you make use of your active listening & communications skills and your influencing skills.
•    Your analytical skills enable you to make sound decisions 
•    Of course, you fulfil your role with integrity & ethics at all times 
•    You are open to limited business travel