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Kerr Sr. Regulatory Affairs Specialist (Orange, CA)

📁
Quality and Regulatory Affairs
💼
Kavo Kerr
📅
805 Total Views
JOB SUMMARY:
The Sr. Regulatory Affairs (RA) Specialist creates, evaluates and completes domestic and/or international regulatory tasks related to the following: submissions (US, CA), EU technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. This individual is responsible for obtaining regulatory clearances based on company objectives, attending product development meetings, project meetings; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities.


PRIMARY DUTIES & RESPONSIBILITIES: 
  • Maintains current knowledge of relevant regulations, including proposed and final rules issued by relevant regulatory authorities that may impact the company.
  • Creates and implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Technical writing of procedures and/or SOPs that link to the international regulatory operations. 
  • Represents and provides regulatory guidance within the cross-functional team and serves as the expert in regulatory affairs for new product development/sustaining projects
  • Strong submission experience with US FDA 510k’s, Health Canada Medical Device License.
  • Responsible for the implementation of regulatory strategies and ensures timely submissions (510s, 513G, device licenses) of products in compliance with applicable regulations and guidance through coordination and preparation of submission documents for the registration of new products and changes to existing products.
  • Support UDI and GUDID database operations.
  • Responsible for FDA requests to ensure customs/trade compliance.
  • Assist with the preparation and compilation of regulatory information requested during government audits/inspections, such as with FDA, Health Canada and Notified Body.
  • EU Technical file experience and strong knowledge of EU Regulation MDD 93/42/EEC and EU MDR 2017/745.
  • Coordinates, prepare and maintains facility registrations, establishments, etc.
  • Maintains clearances within the product registration software system (Register).
  • Review and assess product, manufacturing and labeling changes for regulatory reporting impact and compliance to regulations.
  • Experience identifying, communicating and solving regulatory issues that may arise.
  • Prepare monthly status reports, Key Performance Indicators (KPI) for Regulatory Affairs Management.
  • Perform special projects as needed.
REQUIREMENTS:
  • Bachelor's Degree (BA/BS) from four-year college/university 
  • 5+ years regulatory experience in international registrations.

PREFERRED QUALIFICATIONS:
  • Strong analytical and organizational skills; ability for detail and precision.
  • Team player with ability to work independently.
  • Excellent written and oral communication skills.
  • Project management skills.
  • Good general mathematical skills, strategies and concepts including the ability to calculate figures and amounts such as percentages.
  • Strong interpersonal and presentation skills with the ability to influence others in a positive and effective manner.
  • Strong computer skills in Word, Excel and PowerPoint.
  • Ability to work under minimal supervision.
  • Advanced degree or RAC certification preferred.

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.

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About Envista

Envista is a global family of three companies and more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists’ clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including KaVo Kerr, Nobel Biocare Systems, and Ormco, partner with dental professionals to help them deliver the best possible patient care.


Envista separated from Danaher as an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.

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