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Regulatory Affairs Analyst

2 months ago

Hudson, New Hampshire, United States Atrium Medical Full time

Position Overview:

As a key member of our team, you will be instrumental in ensuring compliance with regulatory standards both domestically and internationally. Reporting directly to the Regulatory Affairs Director, your role will encompass a variety of responsibilities that are critical to our operations.

  • Compliance Management: Oversee internal, national, and global compliance initiatives, ensuring adherence to all regulatory requirements.
  • Regulatory Strategy Support: Collaborate with the Regulatory Affairs Director to develop and implement regulatory strategies and plans.
  • Submission Preparation: Prepare and manage worldwide regulatory submissions and registrations, ensuring all documentation is accurate and timely.
  • Labeling and Promotional Review: Engage in the assessment and approval process for labeling, promotional materials, and product modifications.
  • Documentation Coordination: Prepare necessary documentation and coordinate activities related to PMA's, 510k's, and IDE's.
  • Engineering Change Support: Assist in documenting engineering changes in compliance with Quality Systems Regulations (QSR) and other relevant international regulations.
  • Cross-Functional Collaboration: Participate in cross-departmental projects and product development meetings to ensure regulatory considerations are integrated.
  • Agency Communication: Provide support to the Regulatory Affairs Director in communications with regulatory agencies, including the Food and Drug Administration (FDA) and European Notified Bodies.
  • Compliance Documentation: Ensure all FDA, ISO, MDD, and CMDR compliance documentation is maintained and up to date.
  • Project Assistance: Contribute to special projects as required, demonstrating flexibility and teamwork.
  • Team Contribution: Support the team by accomplishing related duties as assigned.

Qualifications:

A Bachelor's Degree in a Scientific or Engineering discipline is required, along with a minimum of three years of experience in a regulatory environment. The ideal candidate will possess the ability to manage multiple projects in a fast-paced setting and assist in regulatory planning for both domestic and international submissions. Strong communication skills are essential for representing Regulatory Affairs across departments.

Company Overview:

Atrium Medical Corporation is committed to providing competitive salaries and exceptional benefits in a business casual environment. We are an equal opportunity employer dedicated to workforce diversity and maintaining a drug and smoke-free workplace. Drug screening is a standard part of our hiring process.