Senior Regulatory Affairs Specialist

Growing international medical device company is looking for a Sr Regulatory Affairs Specialist to add to their team. This person will be responsible for developing strategies for global approvals to introduce new products (Class II and III) to market, maintain existing products, provide advice on regulatory requirements, prepares worldwide submissions and negotiates their approval with global regulatory agencies. In addition, this position also assists with the training of junior regulatory affairs associates and provides work direction on projects of large scale with significant business impact. This is a direct hire position with great benefits, perks and career growth opportunities!

• Bachelor's degree in Electrical Engineering, Biomedical Engineering, Regulatory or related discipline and a minimum 4 years of experience in medical device, OR Advanced degree in a scientific discipline with a minimum 3 years of experience in medical device.
• 3-5 years medical device industry experience (Class III highly desired, EU and US regulator experience)
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
• History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.
• Experience with MDR submissions and amendments
• Experience working with Software as a medical devices (SaMD) and/or medical devices with electrical/firmware.
• Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, IEC 60601, IEC 62304, and other global regulatory requirements and quality standards
• Experience performing advertising and promotion reviews for medical devices
• Ability to effectively manage multiple projects and priorities.
• Strong communication and regulatory writing skills
• Project management skills