Key Skills

Job Description

Job Description As a consultant, you will be embedded in a high-tech innovation environment, supporting Quality Assurance and Regulatory Affairs activities for regulated medical products across international markets. You will contribute to the operational maintenance and continuous improvement of quality systems, with a focus on CAPA management, SOP development, post-market surveillance and regulatory submissions. Working closely with cross-functional stakeholders and international manufacturing teams, including suppliers, you will help ensure regulatory compliance across the EU, US, EMEA and other relevant markets. Responsibilities Maintain and improve Quality Management System (QMS) processes, ensuring alignment with applicable international regulatory requirements. Manage and follow up on CAPA activities, including root cause investigations, corrective actions and preventive measures. Review, update and develop Standard Operating Procedures (SOPs) and related quality documentation. Support Post-Market Surveillance (PMS) activities, ensuring appropriate monitoring, documentation and follow-up. Contribute to Regulatory Affairs activities, including the preparation and coordination of regulatory submissions across international markets. Support compliance activities related to data privacy and applicable regulatory requirements across the EU, US and EMEA. Collaborate with international manufacturing and supplier teams, particularly in China, to address quality and compliance topics. Coordinate with internal stakeholders to ensure timely execution of operational Quality and Regulatory activities. Skills & Experience Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Quality Management, Regulatory Affairs or a related field. Initial hands-on experience in Quality Assurance and/or Regulatory Affairs within the medical device industry. Basic knowledge of Quality Management Systems (QMS), CAPA management and root cause analysis. Experience reviewing, maintaining or developing SOPs and other controlled quality documentation. Understanding of Post-Market Surveillance (PMS) processes and relevant regulatory requirements. Familiarity with international regulatory frameworks, particularly EU MDR, FDA requirements and other applicable EMEA regulations. Basic understanding of regulatory submissions and market-specific documentation requirements. Awareness of data privacy requirements and their application within regulated environments. Structured and organised approach to documentation, process management and quality-related activities. Strong communication and collaboration skills, with the motivation to learn, take ownership and work with international stakeholders. 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 reason, we welcome applications from all qualified candidates, regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics. Who are we? Amaris Consulting, part of Mantu is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success. 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!

Core Responsibilities

Maintain and improve quality systems, manage CAPA activities, develop controlled documentation, and support post-market surveillance and regulatory submissions for medical products. Coordinate quality and compliance work with internal stakeholders, international manufacturing teams, and suppliers across relevant markets.

Requirements

A bachelor's or master's degree in life sciences, biomedical engineering, quality management, regulatory affairs, or a related field is requested, along with initial hands-on experience in medical-device quality assurance or regulatory affairs. Candidates should have foundational knowledge of QMS, CAPA, SOPs, post-market surveillance, international regulatory frameworks, data privacy, and strong organizational and communication skills.