Regulatory Affairs Specialist

Position Summary

This Regulatory Affairs Specialist is responsible for preparing submissions to various regulatory agencies and maintaining compliance domestically and internationally. Candidates must work well in a team environment, demonstrate great attention to detail, and possess strong communication skills across functions.

• Prepare and submit regulatory documentation, such as FDA 510(k) premarket notifications, to regulatory agencies including FDA, Notified Bodies, and Authorized Representatives.
• Maintain and submit European Medical Device Directive and European Medical Device Regulation compliant Technical Files.
• Create and modify regulatory procedures to remain in compliance with FDA, ISO, European, Canadian, and other standards.
• Work with the international department on regulatory filings for product registration in different countries.
• Provide regulatory support for other projects as required.
• Update personnel on new and revised processes and procedures.
• Process, execute, organize, and archive internal documentation related to Engineering and/or Quality Systems.
• Prepare change order documentation and route it for final approval.

• Minimum of 2-year college degree;
  Bachelor’s Degree (or greater) preferred.
• Relevant work experience, preferably in the medical or legal field and/or other regulated industry.
• Previous experience creating and revising labels and DFUs preferred.
• Knowledge of European, ISO 13485, and FDA regulations preferred.
• Knowledge of international regulatory guidelines regarding GMP requirements is desirable.

• Mental:
  Effectively communicate with others; complete and understand complex situations; analyze numbers; read, analyze, and interpret written materials; work with team to meet and exceed company standards; maintain positive working relationships; troubleshoot and solve problems.
• Physical:
  Communicate for hours at a time; use computer equipment; moderate noise level; limited exposure to physical risk.

• Insurance:
  Major medical, dental, and vision insurance at the first of the month following 30 days of service.
• Other Benefits:
  Hospital indemnity, critical illness, term life insurance & long-term disability (company paid), among others.
• 401(k):
  Matches 100% of contribution, up to 3% of salary.
• Paid Time Off (PTO):
  Nine paid holidays plus PTO based on length of service starting day one.

• Family-oriented, positive working environment
• Discretionary yearly raises
• On-site vending & gym
• Annual employee appreciation picnic
• Tuition reimbursement
• Employee referral bonus program
• Employee assistance program

AMT is an Equal Opportunity/Affirmative Action Employer.