Senior Regulatory Affairs Specialist

Cepheid Orange , CA 92856

Posted 3 weeks ago

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)

Supervisory Responsibilities:
This job has no supervisory responsibilities.

Requirements:

  • Bachelor's Degree (BA/BS) from four-year college/university and/or 3-5 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.

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.

IND-KAV1

#LI-CY1


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Regulatory Affairs Specialist

Radiometer

Posted 3 months ago

VIEW JOBS 1/31/2019 12:00:00 AM 2019-05-01T00:00 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) Supervisory Responsibilities: This job has no supervisory responsibilities. Requirements: * Bachelor's Degree (BA/BS) from four-year college/university and/or 3-5 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. 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. IND-KAV1 #LI-CY1 Radiometer Orange CA

Senior Regulatory Affairs Specialist

Cepheid