Regulatory Affairs Specialist for Medical Devices
4 settimane fa
We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to 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.
- 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.
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