REGULATORY AFFAIR SPECIALIST

Broadata Communications, Inc. is seeking a Regulatory Affairs Specialist to support the company's medical device compliance activities, regulatory documentation, and quality system requirements.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related technical discipline
• Minimum 8-10 years of experience in Regulatory Affairs, Quality Assurance, or Compliance within a medical device environment
• Hands-on experience with Class I medical devices required
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, and medical device documentation requirements
• Experience supporting technical documentation, DHF/DMR files, change control, labeling review, and audit preparation
• Strong attention to detail and ability to manage documentation in a controlled QMS environment
• Ability to work cross-functionally with Engineering, Quality, Operations, and external customers
• Strong written and verbal communication skills
• Ability to organize regulatory information clearly and respond to customer or auditor requests in a professional manner

Benefits

• Medical, vision and dental insurance
• 401(k) with company match (100% of the first 4% in eligible compensation)
• Flexible Spending Account
• 2 weeks paid vacation
• 1 Week sick pay
• 10 company holidays
• Group life insurance