Key Responsibilities:

Conduct thorough research and analysis of current laws, regulations, and standards related to medical devices, both domestically and internationally
Interpret and apply regulations to product development and manufacturing processes
Develop and maintain regulatory strategies for new and existing medical devices
Prepare and submit regulatory submissions, such as 510(k) applications, technical files, and design dossiers
Communicate with regulatory agencies to ensure timely and successful approval of submissions
Collaborate with cross-functional teams, including R&D, Quality Assurance, and Marketing, to ensure regulatory compliance throughout the product life cycle
Monitor and track changes in regulations and communicate potential impact to the company
Participate in internal and external audits to ensure compliance with regulations and company standards
Train and educate team members on regulatory requirements and updates
Act as a liaison between the company and regulatory authorities, responding to inquiries and requests for information as needed

Qualifications:

Bachelor's degree in a scientific or technical field
Minimum of 3 years of experience in medical device regulatory affairs
Thorough knowledge of FDA regulations, ISO standards, and other international regulations
Experience with preparing and submitting regulatory submissions
Excellent analytical and problem-solving skills
Strong attention to detail and ability to manage multiple projects simultaneously
Excellent communication and interpersonal skills
Ability to work independently and as part of a team
Proactive and self-motivated with a strong sense of ownership and accountability

Join our team and make a positive impact on the healthcare industry by ensuring the safety and effectiveness of our medical devices.

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