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
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
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
Scope: Domestic and International (when applicable)
This job has no supervisory responsibilities.
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
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.
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.
Danaher Corporation and all Danaher 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.