Regulatory Specialist

As a Regulatory Affairs Specialist, you will be responsible for maintaining accurate records of regulatory submissions, approvals, and correspondence with regulatory agencies. You will have the following key responsibilities: - Prepare, review, and submit regulatory documents, including applications, reports, and renewals, to relevant regulatory agencies. - Determine the types of regulatory submissions or internal documentation required for situations such as proposed device changes. - Develop and implement regulatory strategies to ensure compliance with domestic and international regulatory requirements. - Monitor regulatory changes and updates closely, assess their impact on current and future products, and advise internal stakeholders accordingly. - Manage product licenses, ensure compliance with regulatory requirements, and coordinate with regulatory authorities. To qualify for this role, you should possess the following qualifications: - Bachelor's degree in a related field such as Regulatory Affairs, Life Sciences, or a similar discipline. - Proven experience working in regulatory affairs within the medical device industry. - Strong understanding of domestic and international regulatory requirements and guidelines. - Excellent communication skills and the ability to collaborate effectively with internal and external stakeholders. Please note that this is a full-time and permanent position with a day shift or fixed shift schedule. Additionally, a yearly bonus is provided. The work location is in person.,