Sr. Regulatory Affairs Specialist

Responsibilities

• Author and submit applications 510(k), PMA Supplements and Technical Documentation to receive product clearance/approvals for new products and maintain existing registrations globally.
• Author and maintain Technical Files compliant to the MDD 93/42/EEC and Technical Documentation compliant to the EU MDR 2017/745.
• Communicate with Regulatory Agencies regarding submissions, and changes of products, including manufacturing, design and new product development.
• Subject Matter Expert to represent Regulatory during internal audits and external audits by regulatory agencies.
• Participate on cross-functional teams for projects as assigned.
• Review protocols and reports for scientific validity and compliance to regulatory standards and provide scientific judgement to guide cross functional teams.
• Perform Regulatory Assessments for design, manufacturing, and labeling changes to ensure compliance with regulations and standards where the product is registered.
• Research requirements and set priorities while maintaining project schedules.
• Provide guidance and oversight to team members related to regulatory compliance.
• Reviewing marketing literature for compliance with applicable regulations and company policies and procedures.
• Execute additional responsibilities as defined by management.

Requirements

• Bachelor’s Degree in Life Sciences, Engineering or other related discipline.
• 5 years of experience in Regulatory Affairs, preferably in the medical device industry.
• FDA, EU, Health Canada, Brazil, Japan, and Australia registration experience.
• Ability to develop clear, concise, and timely oral and written communication and reports.
• Excellent communication skills, oral and written, with all levels of personnel.
• Must be detail oriented and possess considerable organizational skills.
• Experience with electromechanical and implantable medical devices and human tissue regulations is desirable.
• Ability to effectively partner with employees, management, department, and cross-functional teams to meet performance objectives and to support mission and vision of the Company.