Regulatory Affairs Specialist
  • Boston, Massachusetts, US
  • +914043515100
419 Days ago
Job Description

Responsibilities:

  • Maintenance of domestic and foreign regulations and quality standards
  • Works with and responds to inquiries from regulatory agencies.
  • Respond to product questionnaires from customers.
  • Maintains Technical Files in compliance with the European Medical Device Directive
  • Prepare and provide regulatory information and documents needed for product import or export.
  • Collaborate with Sales and Marketing personnel to identify global regulatory requirements for international product registrations.
  • Issuance of certificates of origin and/or conformity as requested.
  • Request FDA Certificate to Foreign Government, Certificate of Exportability as needed
  • Process document legalization, authentication and apostille as needed.
  • Support the preparation and submission of product applications and license amendments to Health Canada.
  • Provide support, create, and maintain documents, correspondence, memorandums, etc. pertinent to Quality Assurance and Regulatory Affairs activities
  • Maintain Establishment Registrations, Device Listings and State Licenses

Requirements:

  • Minimum 5 years knowledge and experience in Regulatory Affairs and Quality Assurance in the manufacture of sterile, disposable medical devices
  • B.S. in Business or a related technical field preferred
  • Strong understanding of FDA Quality System Regulations, Medical Device Directive, and ISO 13485 regulations
  • Proven ability to maintain ongoing compliance in a regulated environment.
  • Able to organize and maintain detailed regulatory and quality records/documentation.
  • Excellent written and verbal communication skills
  • Works well independently and as a team member
  • Knowledge and/or experience in internal and external quality audits
  • Has a desire to function as a team member by listening, asking questions, collaborating, and contributing on daily basis.
  • Organized and able to perform in a time-sensitive environment.
  • Comfortable with prioritizing and managing multiple assignments.
  • Demonstrates a flexible and collaborative approach with various cross-functional teams.
  • Able to draw on diplomatic communication skills.
Industry
  • NA

Required Skills
  • Regulatory Affairs Specialist

Experience
  • 5 Years of Experience

Salary
  • NA

Working Hours / Week
  • 40h