Regulatory Affairs Specialist II

Regulatory Affairs Specialist II will be responsible for preparing US and International regulatory submissions, maintaining compliance with FDA and international requirements, and collaborating with cross-functional teams to ensure timely product launches.

Requirements

• Maintain the company's medical device listing and device establishment registrations
• Prepare domestic and international regulatory submissions, additional information request responses, and renewals
• Review and approve labeling, promotional materials, and publications
• Create and maintain package inserts
• Maintain compliance of distribution control database
• Handle FDA customs import/export requests, customer service needs, and other requests from internal customers
• Write and revise department standard operating procedures (SOP’s)
• Review and approve engineering change requests for design, manufacturing, and labeling changes
• Work with consultants to manage all submissions for a particular country or countries
• Assist senior regulatory staff with regards to regulatory strategies, submissions, and discussions/negotiations with regulatory authorities
• Participate in project teams to develop regulatory strategies, testing requirements, and other documentation
• Participate in new-hire employee selection process
• Mentor new hires as requested by management
• Review and approve surgeon evaluation and prototype devices
• Perform other administrative tasks, as necessary

Benefits

• Medical
• Dental
• Vision
• Maternity Leave
• Life Insurance
• Short-Term Disability
• Long-Term Disability
• Bereavement
• 401(k) (up to 4% match with vesting from day 1)
• PTO (Starting at 18 days each year)
• Paid Holidays (10 each year)
• Employee Assistance Program
• Education Assistance