Compliance and Quality Assurance Specialist
8 hours ago
As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with international regulatory standards and guidelines applicable in our active markets. Your key responsibilities will include:
- Preparing and submitting regulatory documentation required for the approval and registration of new and existing products in various international markets.
- Staying up-to-date on regulatory procedures and changes in the regulatory climate to ensure compliance and advise the company on necessary adjustments.
- Legalizing registration documentation.
- Informing and educating the organization on submission requirements and ensuring necessary documents are provided.
- Maintaining regulatory files and updating regulatory authorizations, such as Investigational Device Exemptions (IDEs), 510(k) submissions, Canadian medical device licenses, and CE dossiers for the EU, as well as NRTL certifications.
- Maintaining registrations, renewals, device listings, site registrations, supplements for changes, and annual reports.
- Responding to questions from regulatory authorities.
- Change control activities.
- Assessing device-related incidents and complaints for medical device reporting requirements. Compiling and submitting reportable events to relevant regulatory authorities in a timely manner. Handling recalls and field actions, if required.
- Reviewing and creating product labels and reviewing promotional materials to ensure compliance with applicable regulations and technical standards.
- Assisting in preparing clinical trial site ethics review board applications for investigational device trials. Preparing interim or final reports for trial site ethics boards as required.
Requirements:
The ideal candidate will possess a Bachelor's degree in a scientific or related field, with an advanced degree preferred. A minimum of 5 years of experience in regulatory affairs, specifically with medical devices, is required. Strong understanding of international regulatory guidelines and standards, such as FDA, CE Marking, NBOG, ISO 13485, MDR, etc., is essential. Proven track record in preparing successful regulatory submissions is also required. Excellent communication skills, both written and verbal, with the ability to interact effectively at all levels of the organization and with regulatory authorities, are necessary. Highly organized and able to manage multiple projects simultaneously in a fast-paced environment, the candidate should also have proficiency in regulatory submission software and document management systems.
About Us:
Magle Chemoswed is a value-driven organization committed to making lives better for patients worldwide. We are a dynamic and growing company that offers a challenging and rewarding work environment. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.
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