Regulatory Affairs Specialist

18 hours ago


Brea, California, United States enVista Full time
Job Description:

The Regulatory Affairs Specialist plays a critical role in ensuring the compliance of our medical devices with global regulations. This individual will be responsible for creating, evaluating, and completing regulatory tasks related to product registration submissions, facility registrations, and special projects. They will work closely with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities.

Key Responsibilities:
  • Stay up-to-date with relevant regulations, including proposed and final rules issued by regulatory authorities.
  • Create procedures and standard operating procedures (SOPs) and technical documentation that link to regulatory operations.
  • Assist in drafting Technical Files and accumulate technical documentation for global product registrations.
  • Implement and coordinate regulatory strategies and plans from senior leadership.
  • Prepare and maintain regulatory submissions, product registrations, certifications, and facility registrations.
  • Work directly with distributors, in-country consultants, inter-company partners, and commercial partners to fulfill regulatory requirements for product registration.
  • Review and assess product, manufacturing, and labeling changes for regulatory reporting impact and compliance.
Requirements:
  • Bachelor's Degree (BA/BS) from four-year college/university.
  • 3+ years of medical device experience, and/or training in an FDA-regulated industry.
  • Advanced degree or RAC certification preferred.
Preferred Qualifications:
  • Master's in Regulatory Science preferred.
  • Demonstrated international submissions experience (i.e., APAC, LATAM, Australia TGA, Health Canada, and/or EU Technical files a plus).
Skills/Qualifications:
  • Ability to challenge the status quo and seek opportunities to set new standards.
  • Ability to take accountability of his/her work, good or bad.
  • Proven ability to prioritize assigned projects and manage time effectively to meet all deadlines.
  • Ability to be flexible and adaptable.
  • Effective collaborator with department and cross-functional team members and comfortable working independently with limited direction/supervision.

Envista is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.


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