RA Manager – medical devices

The Company

Our client, KiOmed Pharma is capitalizing on a history of innovation and expertise in exclusive chitosan
chemistry. KiOmed Pharma, a spinout from KitoZyme, develops a unique pipeline of medical devices
that address unmet medical needs in high impact pathologies and major social burdens such as
invalidating osteoarthritis, aesthetic medicine and ophthalmology.
Located in Belgium, Liège and composed of a fast-growing team, KiOmed Pharma has launched on the
market its first class III CE marked medical device, KioMedineVSone® indicated in the treatment of
symptomatic patients suffering from knee osteoarthritis. A R&D pre-market pipeline of medical devices
is currently under development, more specifically in dermo-aesthetic medicine and ophthalmologic
diseases.

KiOmed Pharma has the ambition and the resources to grow to a worldwide class and aim at succeeding
the commercial launches and growth on its markets.
To support and reinforce their team they are looking for a Regulatory Affairs Manager (RA) including
Market Access from pre market on.

The Position

We have an exciting opportunity for a Regulatory Affairs Manager.
The Regulatory Affairs Manager will be responsible for leading the regulatory strategy from preparation
of registration dossier to post-market follow-up in order to achieve development and marketing goals
for medical devices. He/She leads, in collaboration with other departments, the activities related to
market authorization, registration and vigilance.
The Regulatory Affairs Manager will be reporting of the Chief Operating Officer.

Responsibilities & Accountabilities

The Medical Information Manager is responsible for these overall responsibilities and objectives:

• Support and provide guidance on regulatory issues to internal and external persons on assigned
  projects.
• Execute or support the preparation and maintenance of new and existing documents required
  for regulatory approval for assigned projects.
• Gain and maintain regulatory authority approval and manage follow up post-approval activities,
  including vigilance-related activities, for assigned projects.
• Liaise with regulatory authorities, including notified bodies, as required.
• Participate to product change control activities.
• Monitor legal and regulatory related issues for medical devices, as well as progression in
  standardization work.
• Report to the upper management on any regulatory update or issue impacting the company
  activities.
• Ensure documents are produced in accordance with applicable internal and external procedures,
  guidelines, regulations and standards

  Experience, Skills and Knowledge

• You hold a University degree (Master or Ph.D) with a scientific (preferably medical or
  pharmaceutical) or regulatory affairs orientation.
• You have a 5-years’ experience in regulatory affairs.
• You possess a strong knowledge, understanding and experience concerning European
  regulations and quality systems for medical devices (MDR 2017/745 et ISO 13485). Knowledge
  and relevant experience in other territories (US, China, Brazil) or regulation for medicines
  (Directive 2001/83, GMP) will be regarded as an additional advantage.
• You have strong communication and organizational skills. In addition, you are accurate, selfdisciplined, proficient in multitasking and a real team player.
• You have the ability to analyze and summarize scientific and technical information.
• You have the ability to work across function and in a changing environment.
• You have strong oral and written communication skills in English and French. A proficiency in
  other languages will be regarded as an advantage.

Our clients core values❖ Innovative
❖ Teamwork
❖ Agile and dynamic