We champion creators of confidence.

Senior Regulatory Affairs Manager

Quality and Regulatory Affairs
526 Total Views

The Senior Manager, Regulatory Affairs will provide leadership and management to RA staff at Ormco BU, apply expert knowledge of global medical device regulatory environment, product and regulatory requirement to develop and implement global regulatory strategies.


  • Develops RA strategy for new products and design changes - ensuring regulatory requirements for target markets are met.
  • Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle.
  • Implements business unit (BU) goals and objectives as related to areas of responsibility, and sets Quality goals and objectives for the Regulatory team.
  • Ensures that resources and activities are aligned with the BU objectives. Effectively communicates progress, problems, and plans.
  • Manages and develops team of Regulatory professionals. 
  • Provides appropriate mentoring, appraisals, and discipline of direct reports.
  • Responsible for product registrations, state licenses, and annual reports for Medical Device products globally, through interactions with International Sales Team, in-country business partners and ministries of health.
  • Oversees maintenance, remediation of technical files, MDD/MDR certifications and declarations of conformity in support of EU product registrations/CE mark.
  • Oversee product recalls/field actions, including regulatory reporting per required timelines.
  • Foster and maintain strong relationships with senior RAQA Regulatory leaders across dental platform and leverage best practices and opportunities to drive cross business collaborations and initiatives.
  • Participates in audits and inspections of the company and its quality systems. 
  • Works within a cross-functional, matrixed global organization to drive dynamic performance in all areas.
  • Bachelor’s degree in a scientific discipline.
  • 5+ years in RA role within Medical Devices or Pharmaceutical industries.
  • 3+ years of experience managing a team of RA associates. 
  • Ability to travel up to 10% of the time.

  • Provide strong organizational leadership, ability to organize complex work, drive change and instill a culture of execution, in RA as well as across the broader organization.
  • Attracts, develops, and retains high quality employees, foster employee engagement and professional development.
  • Comprehensive knowledge and experience with global medical device regulatory requirements and product registrations.
  • Possess strong negotiation skills, the ability to interpret and apply regulations, and working knowledge of product development process.
  • Direct experience with preparing and submitting materials for 510(k), MDEL and CE mark.

Envista and all Envista Companies are equal opportunity employers that evaluate 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. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.


Previous Job Searches

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions

Be a champion

At Envista, we believe true champions lift others up.

And they do more than win - they stand for something bigger.

Our Employees are our champions; they work to be their best, help others be theirs, show up every day to make a difference, and celebrate the difference in others.

At Envista, we commit to our teams, our businesses - and above all - the professionals who improve patients' lives.


Transforming the dental industry.

The innovative companies that are part of Envista help dental professionals deliver the best possible patient care, every step of the way.

Kavo Kerr Logo

For more than 100 years, KaVo and Kerr have been serving the needs of dental professionals. As industry leaders, and with rich expertise and product development, we continue to improve our clinical products and services to support dental professionals in the best diagnosis and treatment of their patients.

Learn More
Nobel Biocare Systems Logo

Built on over 60 years of continuous innovation, Nobel Biocare Systems is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications.

Learn More
Kavo Kerr Logo

Ormco has a distinguished 50+ year history of providing the orthodontic profession with high quality, innovative products backed by attentive customer service and educational support.

Learn More
Torell Jackson Employee Testimonial Video 

Torell Jackson Senior Product Manager KaVo Kerr

William Irwin Employee Testimonial Video 

William Irwin Director of International Product Management KaVo Kerr

Employee Testimonial Video 

Poornima Gopalakrishnan Director of Inside Sales KaVo Kerr

“Envista was created with cultural enthusiasm for continuous improvement, personal and professional development, and championing creators of confidence — employees and customers alike.”

Curt Bludworth

Chief Human Resources Officer