Medical Device Regulatory Affairs Specialist

If you are a self-motivated and detail-oriented individual with a strong background in medical device regulatory affairs, we encourage you to apply for this exciting opportunity.

Job Title: Medical Device Regulatory Affairs Specialist

Job Summary: We are seeking a highly skilled and motivated Medical Device Regulatory Affairs Specialist to join our team. In this role, you will be responsible for ensuring compliance with all regulatory requirements for medical devices. You will be the subject matter expert for all regulatory affairs matters and will play a critical role in the development, approval, and maintenance of our medical devices.

Responsibilities:

• Develop and implement regulatory strategies for the approval and marketing of medical devices in various global markets
• Prepare and submit regulatory submissions to regulatory agencies, including 510(k)s, PMAs, and other regulatory filings
• Collaborate with cross-functional teams to ensure that all regulatory requirements are met throughout the product development process
• Conduct regulatory research and stay up-to-date with changes in regulations and guidelines to ensure compliance
• Review and approve labeling, marketing materials, and promotional activities to ensure compliance with regulations
• Participate in regulatory agency inspections and audits
• Maintain regulatory files and documentation in accordance with applicable regulations
• Provide guidance and training to internal teams on regulatory requirements and processes
• Participate in risk management activities to ensure all risks are identified and addressed in accordance with regulatory requirements

Requirements:

• Bachelor's degree in a scientific or technical field, advanced degree preferred
• Minimum of 3-5 years of experience in medical device regulatory affairs
• Strong understanding of FDA regulations and guidelines, as well as international regulations (e.g. CE Mark, Health Canada, etc.)
• Experience with 510(k) submissions, PMAs, and other regulatory filings
• Excellent written and verbal communication skills
• Strong attention to detail and ability to work independently
• Ability to manage multiple projects and priorities in a fast-paced environment
• Knowledge of risk management principles and experience with risk assessment tools
• Experience with medical device quality management systems (ISO 13485) is a plus
• Regulatory Affairs Certification (RAC) is a plus

Benefits:

• Long-term disability insurance
• Competitive salary and benefits package
• Opportunities for professional growth and development
• Collaborative and supportive work environment
• Cutting-edge medical devices that make a positive impact on patients' lives

Join our team and help us bring innovative medical devices to market while ensuring compliance with all regulatory requirements.