Regulatory Affairs Officer

Micreos Human Health B.V. manufactures medical devices for a range of skin diseases under various brands.

We are looking for a Regulatory Affairs (RA) Officer with experience in Quality Assurance (QA) at our location in Bilthoven with the possibility to work from home partially.

Your role at Micreos Human Health B.V.

As our regulatory landscape is converting from the MDD to the MDR we are looking for an ambitious and enthusiastic RA Officer with at least 2 years of experience in the medical this role you are responsible for the regulatory processes compliance and applications/submissions that ensure that our medical devices can reach our patients. Furthermore you will maintain and improve relevant SOPs and participate in audits. The role reports into the Medical & Regulatory Manager.

As RA Officer your main responsibilities/activities will be to:

• 
  Maintain and update the technical documentation risk analysis and affiliated documentation (e.g. biocompatibility and non-clinical verification reports regulatory statements country applications).
• 
  Maintain post-marketing surveillance activities the vigilance work flow and create the affiliated documents (e.g. PSUR).
• 
  Ensure the identification of applicable harmonized standards and guidelines (e.g. MDCG ISO ASTM) and implement their impact.
• 
  Monitor for new or revised regulatory requirements published relevant to the devices manufactured by Micreos Human Health B.V.
• 
  Maintain the regulatory SOPs and train internal stakeholders if necessary.
• 
  Collaborate with Quality marketing and production to ensure that product improvements pursued claims or manufacturing issues are dealt with in a compliant and design-conforming manner.
• 
  Contribute to audits (e.g. ISO 13485 Notified Body); contribute to regulatory stakeholder communications.
• 
  Maintain professional relationships with external stakeholders such as key distributors.

Your competences and opportunities

• 
  At least one year of experience in a regulatory function preferably with class IIa products or higher.
• 
  2 years of working experience in a medical device or affiliated company (other roles may have included e.g. R&D QA).
• 
  MDR experience is preferred.
• 
  Experience with Design & Development and with therapeutic medical devices (e.g. in dermatology or an affiliated field) is preferred.
• 
  The team can rely on your honesty.
• 
  You are involved and collegial and prioritize the right processes to ensure that the business can thrive now and on the long-term.
• 
  You are pragmatic in terms of short-term issues when the situation permits.
• 
  You work in a small team with the opportunity to dive into all aspects of regulatory compliance.
• 
  You work in an inclusive team in which we believe that a good balance in personalities nationalities and life experiences builds mutual respect and a pleasant work atmosphere.

Keywords related to your personality

• 
  Curiosity: You learn rapidly and eagerly and seek to understand our strategy market customers and suppliers.
• 
  Communication: You maintain open and trustworthy relations with your colleagues can remain calm in stressful situations and listen well.
• 
  Courage: You voice your opinion concerns or possibilities even if these may be controversial.

Our offer
METCH offers a varied role within an enthusiastic team. The salary offered is in line with market conditions and you will be given the opportunity to make the fullest use of your talents. We offer you an ambitious and pleasant international working environment.

Is this the role you are looking for

Our METCH HR team is looking forward to receiving your CV and cover letter via

Please only apply if you are eligible to work in the Netherlands.

Company profile:

Micreos Human Health B.V. is a manufacturer of substance-based medical devices (i.e. creams gels) that include an innovative protein that stems from endolysin and phage technology. Micreos Human Health B.V. produces these medical devices for the inflammatory skin conditions acne eczema and rosacea.

Micreos Human Health B.V. is a subsidiary of METCH B.V. METCH is committed to advancing consumer applications for endolysin technology and stewarding skin microbiome health. We believe that everyone deserves healthy skinand that a balanced microbiome supports the skins ability to heal.

Acquisitions following this vacancy are not appreciated.