Regulatory Affairs Manager for Device Development

2 days ago


Irvine, California, United States Allergan Aesthetics Full time

At Allergan Aesthetics, we strive to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.

Salary

We offer a competitive salary range of $115,000 - $150,000 per year, based on experience and qualifications.

About the Job

The Sr Manager Regulatory Affairs represents regulatory affairs for device development and/or marketed product projects. This role is responsible for developing, communicating, and executing regulatory strategic plans to Global Regulatory Lead (GRL) and project team.

Key Responsibilities:

  • Develop US/EU regulatory filing strategy with minimal supervision.
  • Provide regulatory strategy and guidance to global product owner/project team in line with commercial objectives.
  • Collaborate with GRL/regulatory/cross functional team to resolve complex project issues.
  • Critically review complex reports, validations, etc. for scientific merit and regulatory appropriateness.
  • Ensure planned device development activities comply with US/EU regulatory guidelines.

Requirements:

  • Education equivalent to a BS degree in a scientific field, plus 8 years' experience in regulatory affairs; or
  • Education equivalent to a MS degree in a scientific field, plus 6 years' experience in regulatory affairs; or
  • Education equivalent to a PhD degree in a scientific field, plus 4 years' experience in regulatory affairs.
  • Experience in US medical devices regulatory affairs is necessary.
  • Demonstrated experience of submissions to FDA as a primary contact and lead meetings with FDA.

What We Offer:

  • A comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our short-term incentive programs.
  • This job is eligible to participate in our long-term incentive programs.

About Us

Allergan Aesthetics is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.



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