Regulatory Compliance

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Compliance Officer

Job Title: Regulatory Affairs Specialist

Job Responsibilities:

This position is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies.

General Description and Duties:

To effectively and efficiently perform important tasks of this role, the successful candidate must possess the necessary knowledge, skills, and abilities. Flexibility will be available to accommodate individuals with disabilities.

  • Provide guidance on strategic and contingency planning by interpreting and developing regulatory strategic plans.
  • Represent the regulatory affairs team in product development and commercialization activities.
  • Ensure compliance with relevant standards and take corrective actions. Serve as the point of contact for domestic and international customers and vendors.
  • Prepare and manage documentation packages for submission to regulatory agencies. Keep track of timelines, milestones, and interact with regulatory agencies during submission review and audits.
  • Assist with customer complaints and corrective and preventive action (CAPA) systems.
  • Develop and review risk assessment processes for existing devices and adapt risk management procedures as necessary.
  • Monitor and assess the impact of proposed and current regulations and guidance from US and EU regulatory bodies.
  • Evaluate and review regulatory claims, promotional materials, labeling content, product and process changes, and product documentation.
  • Collaborate with and receive direction from regulatory affairs management.

Projects and Other Duties:

  • Perform any additional assigned tasks as needed.

Position Qualifications

  • Thorough knowledge of US and EU regulations that impact Class III medical devices.
  • Experience in cross-functional projects.
  • Fluency in English with excellent written and verbal communication skills.
  • Strong analytical and problem-solving abilities.

Minimum Education:

  • Bachelor’s degree in a related field with a preference for a scientific degree.

Minimum Experience:

  • At least 3 years of experience in a regulatory or related role.

Salary:

Aligning our overall business objectives with performance and merit based pay, Our Client offers competitive salaries, performance-based incentives, and Employer paid benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $80,000 to $120,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

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