Regulatory Affairs Specialist

**Title** : Regulatory Affairs Specialist with a Specialty in Labeling

**Location** : Redondo Beach, 100% onsite

**Shift** : M-F, standard working hours

**Pay** : $40-$45/hr

**Temp to Hire**

**Job Responsibilities** :

+ Drives discussions with Global/Platform RA, Research & Development, Clinical, and relevant cross-functional partners to ensure that China requirements are understood and integrated early in the product development process where/when possible.

+ Leads required discussions and collaborations for China-specific requirements to assess new or revised health authority requirements.

+ Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations.

+ Partners with other functions and Subject Matter Experts (SME's) to obtain information and/or data required for regulatory submissions.

+ Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.

+ Contributes to global product registration maintenance, including EU MDR Technical Documentation/MDD Technical Files and Global Submission Summary Document.

+ Participates in preparation for and during internal and external regulatory audits.

+ Compiles materials required for new global product submissions, license renewals, and change submissions.

+ Requests, obtains, and maintains FDA Certificates to Foreign Government (CFGs) including notarization and legalization, EC/ISO certificates, and various other regulatory documents.

+ Initiates root cause investigations for translation vendor-driven non-conformances and CAPA/SCAR investigations and ownership.

**Requirements** :

+ Bachelor's degree in related field

+ 3-5 years of direct regulatory experience in a medical device company

+ Experience with multiple jurisdictions such as EU, US, and Asia.

+ EU MDR technical documentation experience

+ Experience managing tasks or projects. Basic project management skills.

+ Regulatory Affairs Certification is preferred but not required.

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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.