At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
Job description
Location: Best, Netherlands
Company: Amaris Consulting (part of Mantu Group)
Client Site: Leading Global MedTech Company
About Amaris Consulting:
Amaris Consulting is a global technology and management consulting firm. We connect talented professionals with exciting projects at leading companies worldwide. We are currently seeking an experienced Regulatory & Compliance Consultant to join our team and work on-site in Best, supporting a high-impact strategic project in the field of circular economy and refurbished imaging systems.
Role Overview:
As a Regulatory & Compliance Consultant, you will support the development of a regulatory and compliance framework for circular economy and refurbished imaging systems. Your responsibilities will include analyzing local regulatory requirements in emerging markets (Brazil, India, China), supporting business case documentation, drafting compliance SOPs, and integrating circular economy principles into the quality management system.
Key Responsibilities:
Analyze and interpret local regulatory requirements for refurbished medical devices in emerging markets (Brazil, India, China). Support the preparation of business case documentation and go-to-market strategies. Draft compliance SOPs and create audit-ready documentation for reuse and refurbishment programs. Integrate circular economy principles into the quality management system. Collaborate with cross-functional teams (regulatory affairs, quality assurance, engineering, sustainability, legal). Prepare or contribute to regulatory dossiers, compliance matrices, and market access strategies. Ensure alignment with WEEE regulations, ISO 13485, EU MDR, IEC 60601, and country-specific regulations (ANVISA, CDSCO, NMPA). Utilize QMS tools and digital traceability systems to support product lifecycle management.Key Qualifications:
7+ years of experience in medical device quality, regulatory affairs, or sustainability programs. Proven track record with circular economy frameworks and refurbishment programs, ideally in an OEM or Tier 1 MedTech environment. Deep understanding of WEEE regulations, ISO 13485, EU MDR, IEC 60601, and country-specific regulations (ANVISA – Brazil, CDSCO – India, NMPA – China). Experience preparing or contributing to regulatory dossiers, business case reports, and market access strategies for emerging markets. Skilled in drafting SOPs, compliance matrices, and audit-ready documentation related to reuse/refurbishment. Familiarity with product lifecycle management, QMS tools, and digital traceability systems. Ability to collaborate with cross-functional teams (RA, QA, engineering, sustainability, legal).Soft Skills:
Strong analytical and structured thinking. Clear communicator, able to translate technical/regulatory content into business-level insight. Project-oriented and proactive, able to work independently or lead a small task force.Preferred Background:
Experience in imaging systems or other high-end diagnostic medical devices. Consulting or cross-border collaboration experience. Technical background in biomedical engineering, industrial engineering, or quality management.What We Offer:
Opportunity to work on a high-impact, strategic project in Best. Dynamic and innovative work environment. Professional growth and development opportunities. Potential for long-term collaboration. Ongoing support from Amaris Consulting throughout your assignment.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.