We champion creators of confidence.

Sr. Regulatory Affairs Specialist

📁
Quality and Regulatory Affairs
💼
Kavo Kerr
📅
873 Total Views
Position Overview:
The Senior 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.

Essential Duties and 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 and/or 5+ years regulatory experience
Preferred Skills/Abilities:
  • 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
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to sit. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 10 pounds.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

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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Kavo Kerr

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