Key Skills

Job Description

Job Description Join our team and start a new adventure in an international and dynamic environment, where you will be able to fulfil your career expectations in a fast-growing organization. You will: Provide strategic regulatory input throughout the product development lifecycle. Support the creation and execution of departmental regulatory strategy plans. Manage product registrations and approvals in global markets (FDA, MFDS, NMPA, EU, and others). Monitor regulatory procedures and changes to ensure ongoing compliance. Play a key role during external audits and notified body inspections. Review and recommend updates to labeling and design documentation. Report on global regulatory roadmaps and align them with marketing and product strategies. Act as a regulatory ambassador, upholding company values and compliance standards. Your profile Academic background: Technical Bachelor and/or Master’s degree. Experience in regulatory affairs for medical devices, including global submissions (FDA, Health Canada, EU MDR, etc.). Experience with regulatory documentation and labeling reviews. Deep understanding of global regulatory and legislative initiatives. Knowledge of product lifecycle management and post-market compliance. English fluent. Additional languages are a plus. You demonstrate strong communication and stakeholder management skills. You are comfortable navigating audits and regulatory inspections. You thrive in a fast-paced, culturally diverse global environment. You are process-oriented with a proactive mindset. What We Offer An international community, bringing together 110+ different nationalities An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities A robust training system with our internal Academy and 250+ available modules 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 Who are we? Amaris Consulting 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

The Regulatory Specialist will provide strategic regulatory input throughout the product development lifecycle and manage global product registrations. They will also monitor regulatory changes, ensure compliance, and act as a key point of contact during external audits and inspections.

Requirements

Candidates must hold a technical Bachelor or Master’s degree and possess significant experience in regulatory affairs for medical devices. Proficiency in global submissions, regulatory documentation, and English fluency are essential for this role.

Benefits

• Training system
• Internal academy
• Inclusive working environment