Location: Brazil (Remote opportunity)
Join our team and start a new adventurein an international, dynamic, and highly regulated environment, where you can grow your career within a rapidly expanding organization.
Being a consultant atAmaris Consultingmeans positioning yourself as a technical and functional reference inRegulatory Affairs, acting as a strategic partner to our clients thanks to:
Yourleadership and communication skills, enabling you to build trusted relationships with internal and external stakeholders.
Yourcritical and regulatory mindset, allowing you to anticipate risks and propose solutions aligned with current regulations.
Yourcuriosity and continuous learning, supporting clients across multiple industries in complex regulatory contexts.
Your missions
LeadRegulatory Affairs activities for medical devices, ensuring compliance with European regulations (EU MDR – Regulation (EU) ********).
Act as an expert inmedical device classification, with a focus onClass IIa and IIb, ensuring correct application of classification rules.
Coordinate thepreparation, review, and maintenance of technical documentation(EU MDR Annexes II and III).
Provide expert support inCE Marking processes and conformity assessments, including direct interaction withNotified Bodies.
Analyze and manageregulatory changes, assessing their impact on the product portfolio and defining regulatory strategies.
Advisequality, clinical, R&D, manufacturing, and supply chain teamson regulatory matters throughout the device lifecycle.
Lead responses toobservations, questions, and non-conformitiesraised by health authorities and Notified Bodies.
Ensure compliance withpost-market requirements, when applicable (PMS, PMCF, vigilance).
Propose and leadimprovements in regulatory processes, optimizing timelines, documentation quality, and compliance.
Your profile
6+ years of experiencein Regulatory Affairs for medical devices.
Proven experience withEuropean regulations (EU MDR).
Strong expertise inClass IIa and IIb medical devices.
Experience working withNotified Bodies and health authorities.
Solid knowledge of theregulatory lifecycle of medical devices(registration, maintenance, changes, and post-market activities).
Academic background inPharmaceutical Chemistry, Biomedical Engineering, Pharmacy, Health Sciences, or a related field.
Advanced / fluent English(spoken and written).
Stronganalytical, decision-making, and prioritization skills.
Leadership, autonomy, and stakeholder managementskills 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.
