Job Description

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 ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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