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Dentsply Sirona

With Dentsply Sirona, you can advance with confidence.

Regulatory Affairs Manager

ComplianceComplianceFull TimeRemoteSeniorTeam 10,001+Since 1899H1B SponsorCompany SiteLinkedIn

Location

North Carolina

Posted

7 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Regulatory Affairs Manager

Dentsply Sirona

• Overseeing the day-to-day functions of the Dentsply Sirona Implants and Prosthetics team. • Developing regulatory strategies for existing, new, and modified medical devices and other (regulated) products. • Managing and submitting 510ks for the products and managing communications with FDA including pre-subs. • Mentoring and providing guidance to direct reports and cross-functional product development teams on US and EU regulatory requirements. • Working closely with business partners for registrations in their respective countries to ensure compliance globally.

Job Requirements

  • Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline.
  • 5(+) years of experience in regulatory affairs, preferably in the medical device industry.
  • Experience with leading regulatory submissions and managing regulatory projects.
  • In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR).
  • Experience with software as a medical device, AI and/or medical devices containing software is a plus.
  • Proficiency with Microsoft Office Suite.
  • Proficiency with Regulatory software.

Benefits

  • Competitive salary
  • Flexible working hours
  • Professional development budget
  • Home office setup allowance
  • Global team events

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