What are the responsibilities and job description for the Regulatory Affairs Specialist - Labeling position at Kelly Science, Engineering, Technology & Telecom?
Kelly® Science & Clinical is seeking a Regulatory Affairs Specialist - Labeling for our client based in Bridgewater, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Hybrid Schedule
Ideal locations: Rochester, NY. Clearwater, FL, St Louis MO, or Bridgewater, NJ
Remote option
Length of assignment – 12 months; may extend
Day shift- Monday to Friday must be available to work EASTERN time zone hours
Compensation: $45 - $47/hr DOE
This individual is responsible for leading labeling artwork development/revisions projects for medical device products, and assessing changes in standards, regulations, and requirements to identify impact to product labels. As a key team member, involved in the development of labeling processes and procedures to enhance existing practices.
Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what’s next in your career is what we’re all about.
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 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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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.
Hybrid Schedule
Ideal locations: Rochester, NY. Clearwater, FL, St Louis MO, or Bridgewater, NJ
Remote option
Length of assignment – 12 months; may extend
Day shift- Monday to Friday must be available to work EASTERN time zone hours
Compensation: $45 - $47/hr DOE
This individual is responsible for leading labeling artwork development/revisions projects for medical device products, and assessing changes in standards, regulations, and requirements to identify impact to product labels. As a key team member, involved in the development of labeling processes and procedures to enhance existing practices.
- Manage and coordinate labeling change requests and content updates for US only artwork, MDD, MDR, new product launches, private label or regional/country specific (lens/lens care).
- Work with regional/country requestors to initiate projects/changes
- Liaise with cross-functional SME teams to verify and confirm labeling content
- Perform label assessments using labeling processes, forms and checklists
- Works to resolve any conflicts of reviewer feedback on labeling content
- Work closely with LRS Coordinator to align & interpret LRS into a red line versions of artwork
- Provides continuous feedback to LRS Coordinator on any content changes that would impact LRS updates
- Sit in on LRS meetings with LRS Coordinator
- Act as LRS Coordinator back-up
- Redline and communicate changes with project team and disseminate information to Graphics team for artwork creation
- Perform all assigned ELM project tasks
- Submission artwork support
- Provides RA artwork support for health authority submissions (provides before/after
- artworks, redlined PDFs, etc.)
- Monitors timelines and advises project teams of any impacts to timelines during TG1
- SOP support/review
- Participate in company audits, as needed
- Other job responsibilities as needed
- Knowledge of medical device industry regulatory affairs discipline throughout the product lifecycle including.
- Development, Commercialization, and Operations.
- Knowledge of standards and regulations relating to submissions and regulatory
- approval of device products.
- Knowledge of medical device industry product labeling processes for review and
- obtaining regulatory approvals.
- Strong technology skills and abilities, especially with Microsoft Office programs and web-based programs.
- Ability to critically and efficiently review detailed information to support a labeling revision.
- Demonstrated ability in analytical reasoning and critical thinking skills
- Ability contribute and lead a team environment
- Ability to understand and apply business drivers outside of Regulatory Affairs
- Strong communication skills; both oral and written
- Strong interpersonal skills with the ability to influence others in a positive and effective manner
- Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies; able to do so quickly without sacrificing attention to detail
- Bachelor’s degree or higher preferred. In lieu of degree, 8 years industry experience with applied knowledge of applicable standards, regulations of medical device labeling requirements.
Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what’s next in your career is what we’re all about.
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 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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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.
Salary : $45 - $47