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Regulatory Affairs Specialist
4 months ago
Title: Regulatory Affairs Specialist with a Specialty in Labeling
Location: Redondo Beach, CA- 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 within a medical device company
- Experience with multiple jurisdictions such as EU, US, and Asia in labeling and regulatory submissions.
- EU MDR technical documentation
- Experience managing tasks or projects. Basic project management skills.
- Regulatory Affairs Certification is preferred but not required.
