What are the responsibilities and job description for the Regulatory Affairs Specialist - Medical Devices position at Aura Health?
The Senior Regulatory Affairs Specialist for Medical Devices is responsible for supporting regulatory strategies and compliance throughout the product lifecycle of aesthetic medical devices.
Key duties include managing product registrations across multiple regions, preparing technical documentation and submissions, updating device files, and ensuring compliance with regulations such as FDA and ISO 13485.
This role involves collaborating with cross-functional teams on design changes, labelling updates, and risk assessments, as well as participating in audits and inspections.
Candidates should have 5-7 years of experience in regulatory affairs within the medical device industry, a relevant bachelor’s degree, and knowledge of FDA and ISO standards.
Strong technical writing, regulatory strategy skills, and the ability to manage multiple projects are essential.
Preferred skills include familiarity with EU MDR and APAC regulations.
Offers a hybrid work model, competitive salary, and comprehensive benefits package.
Key duties include managing product registrations across multiple regions, preparing technical documentation and submissions, updating device files, and ensuring compliance with regulations such as FDA and ISO 13485.
This role involves collaborating with cross-functional teams on design changes, labelling updates, and risk assessments, as well as participating in audits and inspections.
Candidates should have 5-7 years of experience in regulatory affairs within the medical device industry, a relevant bachelor’s degree, and knowledge of FDA and ISO standards.
Strong technical writing, regulatory strategy skills, and the ability to manage multiple projects are essential.
Preferred skills include familiarity with EU MDR and APAC regulations.
Offers a hybrid work model, competitive salary, and comprehensive benefits package.