Regulatory Specialist
HeartFlow- Full Time
- Junior (1 to 2 years)
Candidates should possess a Bachelor’s degree in a healthcare-related field and previous experience in the medical devices industry is required. Intermediate to advanced English proficiency is necessary, and knowledge of Ordinance 384/2020, RDC 751/2022, and Quality Standard 665/2022 is preferred.
The Regulatory Affairs Analyst will be responsible for product registrations, item maintenance, certifications, and supporting import clearance processes, prioritizing and managing regulatory submissions for changes and renewals across all risk classes. They will also interact with Health Authorities by preparing and submitting dossiers, responding to inquiries, and monitoring approval status, while providing cross-functional communication and supporting audits and tender processes. Furthermore, the role involves delivering accurate data for monthly KPIs and management reports, maintaining organized RA intelligence files, and identifying opportunities for continuous improvement.
Develops and manufactures medical devices and equipment
Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.