Global Medical Device Regulatory Affairs Specialist

Envista Holdings Corporation; Los Angeles (CA); On-site; USD 86,000 - 105,000; Full time

Job summary

Envista Holdings Corporation's Implant Direct seeks a Regulatory Affairs Specialist to plan, prepare, and manage global submissions for medical devices, including US 510(k), EU technical documentation, and international dossiers.

The role collaborates with cross-functional teams, provides regulatory strategy, ensures compliance, supports audits, and helps navigate evolving regulatory requirements across markets.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or health care-related discipline.
• 3 years of experience in medical devices regulatory submissions.
• 3 years’ experience with successful preparation and submission of 510(k) and international documents and registrations.

Responsibilities

• Plan, prepare, coordinate, track, and obtain clearances for medical device submissions (510(k), EU docs, international) across markets.
• Represent Regulatory Affairs on project teams and assess regulatory impact of changes.
• Coordinate document packages for US, EU, and Canada submissions (510(k), CE, Health Canada).
• Prepare and compile domestic and international product registrations (510(k), CE, CMDCAS, etc.).
• Support audits and liaise with regulatory authorities; review marketing materials.

Skills

Regulatory submissions

510(k)

FDA/Regulators

Regulatory strategy

Cross-functional teams

English communication

Education

Bachelor's Degree

Job description

Envista Holdings Corporation's Implant Direct seeks a Regulatory Affairs Specialist to plan, prepare, and manage global submissions for medical devices, including US 510(k), EU technical documentation, and international dossiers.

The role collaborates with cross-functional teams, provides regulatory strategy, ensures compliance, supports audits, and helps navigate evolving regulatory requirements across markets.