PSL-045 - MEDICAL DEVICE REGULATORY COORDINATOR

Bebeeregulatory


Regulatory Affairs Specialist This role is responsible for supporting the regulatory team with various tasks, including preparation and submission of regulatory filings. The successful candidate will have a strong understanding of medical devices and their use, as well as an intermediate understanding of the regulatory submission process in different regions. Key Responsibilities: - Preparation, assembly, storage, tracking, and retrieval of information pertinent to the regulatory processes - Author and publish electronic submissions for product registrations, renewals, and registration changes - Maintains registration databases, product registration records, key performance indicators current, and communicates approved registrations - Executes registration processes in assigned countries, working closely with business unit regulatory teams to request information and business partners to ensure registrations are submitted on time The ideal candidate will have a bachelor's degree in a life science or related field and at least 3-5 years of experience in regulatory affairs, engineering, quality, or a related field. A minimum of one year of experience in the orthopedic or medical device industry is preferred. Benefits: - Up to 10% travel expectation - A competitive total rewards package - Development opportunities and robust employee resource groups (ERGs) - A flexible working environment and wellness incentives - A culture of recognition and performance awards Requirements: - Bachelor's degree in life sciences or related field - At least 3-5 years of experience in regulatory affairs, engineering, quality, or related field - Minimum one year of experience in orthopedic or medical device industry - English proficiency required - Regulatory affairs certification preferred

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