Senior Regulatory Affairs Specialist - Kelly Services
Brea, CA
About the Job
Position Overview:
The Senior Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. This individual is responsible for obtaining global regulatory clearances/approvals based on company objectives, attending product development meetings, regional alignment; 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.
Location: Brea, CA
Shift : M-F, standard working hours
Hybrid Role
Pay: 45/hr
6-8 month contract role
RESPONSIBILITIES:
+ Assist in the development of 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.
+ Prepare and maintenance technical files, MDD/MDR certifications and declarations of conformity in support of EU product registrations/CE mark.
+ 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 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 registration of products in compliance with applicable regulations and guidance through coordination and preparation of submission documents for the registration of new products and existing products in regulated markets (i.e. US, Canada, Asia-Pac, LATAM, Russia/CIS, China, and MEA-T)
+ Coordinates, prepares, and maintains regulatory submissions, product clearances/approvals, certifications, facility registrations, tender support, etc., according to country registration requirements to facilitate product approvals in all regions
+ Maintains approvals/licenses/authorizations for existing marketing authorizations
+ Complete regulatory assessments and audits of product, manufacturing, Quality Management System (QMS) and labeling changes to assess impact to the user/patient, regulatory reporting, and compliance to regulations
REQUIREMENTS:
+ Bachelor’s degree in a scientific discipline and 4-6 years of work experience in RA role within Medical Device industry. OR
+ Master’s degree and 2 years work experience in RA role within Medical Device industry.
+ Experience authoring 510(k)s, PMA, Health Canada and/or EU Technical File submissions for medical devices preferred
+ Demonstrated experience serving as lead RA representative on cross-functional teams supporting new product development; SaMD experience a plus.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.
Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
The Senior Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. This individual is responsible for obtaining global regulatory clearances/approvals based on company objectives, attending product development meetings, regional alignment; 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.
Location: Brea, CA
Shift : M-F, standard working hours
Hybrid Role
Pay: 45/hr
6-8 month contract role
RESPONSIBILITIES:
+ Assist in the development of 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.
+ Prepare and maintenance technical files, MDD/MDR certifications and declarations of conformity in support of EU product registrations/CE mark.
+ 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 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 registration of products in compliance with applicable regulations and guidance through coordination and preparation of submission documents for the registration of new products and existing products in regulated markets (i.e. US, Canada, Asia-Pac, LATAM, Russia/CIS, China, and MEA-T)
+ Coordinates, prepares, and maintains regulatory submissions, product clearances/approvals, certifications, facility registrations, tender support, etc., according to country registration requirements to facilitate product approvals in all regions
+ Maintains approvals/licenses/authorizations for existing marketing authorizations
+ Complete regulatory assessments and audits of product, manufacturing, Quality Management System (QMS) and labeling changes to assess impact to the user/patient, regulatory reporting, and compliance to regulations
REQUIREMENTS:
+ Bachelor’s degree in a scientific discipline and 4-6 years of work experience in RA role within Medical Device industry. OR
+ Master’s degree and 2 years work experience in RA role within Medical Device industry.
+ Experience authoring 510(k)s, PMA, Health Canada and/or EU Technical File submissions for medical devices preferred
+ Demonstrated experience serving as lead RA representative on cross-functional teams supporting new product development; SaMD experience a plus.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.
Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Source : Kelly Services