We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team.
The Regulatory Affairs Specialist will play a key role in ensuring compliance with regulatory requirements for our medical devices.
This individual will collaborate cross-functionally with internal teams to support product development, registration, and post-market compliance activities.
Key Responsibilities: Prepare and submit regulatory submissions to regulatory authorities, including 510(k) premarket notifications, Technical Files, Design Dossiers, and other regulatory filings as required.
Maintain regulatory files and documentation in accordance with regulatory requirements and company procedures.
Review and interpret regulatory requirements and guidelines to ensure compliance with relevant regulations and standards, including FDA regulations (21 CFR Part 820), ISO 13485, and other applicable standards.
Support regulatory assessments for new product development projects, including regulatory strategy development, risk assessments, and regulatory impact analyses.
Monitor changes in regulations, standards, and guidance documents related to medical devices and communicate updates to relevant stakeholders.
Support post-market surveillance activities, including adverse event reporting, field corrective actions, and regulatory reporting requirements.
Master's degree in Biomedical engineering or relevant discipline.
Minimum of 3 years of experience in regulatory affairs within the medical device industry.
Experience with Class II or Class III medical devices, implantable device experience is a plus.
Knowledge of quality management systems and ISO 13485 requirements.
Strong understanding of FDA regulations, EU Medical Device Regulation (MDR), and international regulatory requirements for medical devices.
Experience preparing and submitting regulatory submissions to FDA and/or other regulatory agencies.
Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory requirements to cross-functional teams.
Detail-oriented with strong organizational skills.
Ability to work independently and collaboratively in a fast-paced environment.
Fluent in English, written and spoken.
Positive attitude during challenging situations.
Good communication skills.
Ottima opportunità di carriera.
RA Specialist Medical Devices