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Regulatory Affairs Specialist
2 months ago
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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