Medical Device Regulatory Affairs Specialist

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

Job Title: Medical Device Regulatory Affairs Specialist

Overview: We are seeking a highly skilled and experienced Medical Device Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a crucial role in ensuring that our medical devices comply with all applicable regulations and standards. This is a dynamic and challenging position that offers the opportunity to work with cutting-edge medical technology and make a meaningful impact on patient care.

Responsibilities:

• Research and stay up-to-date on all relevant medical device regulations and standards, both domestic and international
• Interpret and apply regulatory requirements to the development and manufacturing of medical devices
• Collaborate with cross-functional teams, including R&D, Quality, and Clinical Affairs, to ensure regulatory compliance throughout the product lifecycle
• Prepare and submit regulatory submissions, including 510(k) and premarket approval applications, to regulatory agencies for new and modified medical devices
• Communicate with regulatory agencies to address any questions or concerns regarding submissions or compliance
• Conduct regulatory reviews of labeling, promotional materials, and other documentation to ensure compliance with regulations and standards
• Monitor and track changes to regulations and standards, and provide guidance to internal teams on any necessary updates or changes to processes or procedures
• Participate in internal and external audits and inspections, and assist with any resulting corrective and preventative actions
• Provide support and guidance to international teams on regulatory requirements for global product registrations
• Assist with the development and maintenance of regulatory policies and procedures to ensure compliance with all applicable regulations and standards
• Act as a subject matter expert on medical device regulations and standards, and provide training to internal teams as needed

Qualifications:

• Bachelor's degree in a scientific or technical field, such as engineering, biology, or chemistry
• Minimum of 3-5 years of experience in medical device regulatory affairs, preferably in the development and submission of 510(k) and premarket approval applications
• Strong knowledge of FDA regulations and guidelines, as well as international regulations such as ISO 13485 and MDD/MDR
• Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to both technical and non-technical audiences
• Detail-oriented with strong organizational and project management skills
• Ability to work independently, as well as collaboratively in a team environment
• Experience with regulatory submissions and interactions with regulatory agencies is preferred
• RAC certification or equivalent is a plus

If you are passionate about ensuring the safety and effectiveness of medical devices and making a positive impact on patient care, we encourage you to apply for this exciting opportunity.