Location : Brazil (Remote opportunity)
Join our team and start a new adventure in an international, dynamic, and highly regulated environment, where you can grow your career within a rapidly expanding organization.
Being a consultant at Amaris Consulting means positioning yourself as a technical and functional reference in Regulatory Affairs, acting as a strategic partner to our clients thanks to:
* Your leadership and communication skills, enabling you to build trusted relationships with internal and external stakeholders.
* Your critical and regulatory mindset, allowing you to anticipate risks and propose solutions aligned with current regulations.
* Your curiosity and continuous learning, supporting clients across multiple industries in complex regulatory contexts.
Your missions
* Lead Regulatory Affairs activities for medical devices, ensuring compliance with European regulations (EU MDR – Regulation (EU) 2017/745).
* Act as an expert in medical device classification, with a focus on Class IIa and IIb, ensuring correct application of classification rules.
* Coordinate the preparation, review, and maintenance of technical documentation (EU MDR Annexes II and III).
* Provide expert support in CE Marking processes and conformity assessments, including direct interaction with Notified Bodies.
* Analyze and manage regulatory changes, assessing their impact on the product portfolio and defining regulatory strategies.
* Advise quality, clinical, R&D, manufacturing, and supply chain teams on regulatory matters throughout the device lifecycle.
* Lead responses to observations, questions, and non-conformities raised by health authorities and Notified Bodies.
* Ensure compliance with post-market requirements, when applicable (PMS, PMCF, vigilance).
* Propose and lead improvements in regulatory processes, optimizing timelines, documentation quality, and compliance.
Your profile
* 6+ years of experience in Regulatory Affairs for medical devices.
* Proven experience with European regulations (EU MDR).
* Strong expertise in Class IIa and IIb medical devices.
* Experience working with Notified Bodies and health authorities.
* Solid knowledge of the regulatory lifecycle of medical devices (registration, maintenance, changes, and post-market activities).
* Academic background in Pharmaceutical Chemistry, Biomedical Engineering, Pharmacy, Health Sciences, or a related field.
* Advanced / fluent English (spoken and written).
* Strong analytical, decision-making, and prioritization skills.
* Leadership, autonomy, and stakeholder management skills in international environments.
Amaris Consulting promotes equal opportunities. We are committed to diversity and to creating an inclusive work environment. We welcome all qualified individuals, regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or any other characteristic.