The Regulatory Affairs Manager leads submissions for new medical devices in the US, Canada, Europe, Australia, South America, and other regions. Provides regulatory direction and monitors the progress of submissions. Manages human and material resources within a department or unit; monitors company-wide regulatory and compliance indicators; monitors the external environment in areas of technical or professional responsibility.

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Duties & Responsibilities

  • Write submission documents for FDA, Health Canada, Notified Bodies, and other regulatory agencies, with limited guidance and direction. Develop responses to questions or deficiency letters from regulatory agencies.
  • Design and implement a transition plan to the new MDR regulation
  • Design a system to identify and gather clinical data
  • Compile clinical evaluation reports
  • Maintain MDR system once implemented
  • Maintain MDR compliance
  • Support the maintenance of EUDAMED systems
  • Register products in Europe, and ensure they receive CE marks
  • Maintain and update CE Certificates with new product codes
  • Proactively partner with R&D, Marketing, and other groups to confirm the regulatory requirements necessary to place products on international and domestic markets. Develop and approve appropriate technical documents for regulatory submissions in support of the development project. Advertising, labeling, and promotional materials are included in technical documentation.
  • Develop and maintain Technical Files for CE marking, with limited guidance and direction.
  • Assess the regulatory impact of post-market changes on labeling, design, materials, manufacturing process, sterilization, or packaging.
  • Participate as a member of new product development teams to provide regulatory support to the project.
  • Provides significant guidance and approval regarding regulatory strategies and approaches.
  • Provides direction to management and staff for changes to applicable standards and regulations.
  • Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high-quality staff
  • Participates in team projects and assignments, facilitating or leading teams as necessary.
  • Determines staff assignments and schedules work to meet completion dates and deliverables.
  • Establishes cross-functional team relationships.

Qualifications

  • Bachelor’s Degree in Regulatory, quality, or related technical or scientific discipline. Master’s degree in Regulatory preferred.
  • 10-15 years of experience in regulatory affairs within the medical device industry
  • Strong experience in EU Regulations is required
  • Experience in FDA submissions required
  • Experience in writing/maintaining CE Technical Files preferred
  • Experience in international medical device licensing preferred
  • Excellent problem-solving, decision-making, and root cause analysis skills are required.

Working Conditions

This position works in an open office environment. While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk and sit.

Physical Requirements

Works in an office environment sitting for long periods of time.

Job Type: Full-time

Pay: $110,000.00 – $130,000.00 per year

Benefits:

  • 401(k)
  • Dental insurance
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8-hour shift
  • Monday to Friday

Location: Valencia, California

Education:

  • Bachelor’s (Preferred)

Experience:

  • medical device: 5 years (Preferred)
  • Regulatory Affairs: 6 years (Preferred)
  • FDA regulations: 6 years (Preferred)

For more information please visit: https://trimedortho.com/about-trimed/

Department: Regulatory Affairs
Position: Corporate Position
States: California
Job Location: TriMed Headquarters

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