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Regulatory Compliance Specialist
2 months ago
Position: Regulatory Compliance Specialist with Expertise in Labeling
Location: Redondo Beach, CA - Onsite Role
Work Schedule: Monday to Friday, standard hours
Compensation: $40-45 per hour
Employment Type: Temporary to Permanent
Key Responsibilities:
- Facilitates discussions with Global/Platform Regulatory Affairs, Research & Development, Clinical teams, and other relevant partners to ensure that regulatory requirements for China are clearly understood and integrated early in the product development lifecycle.
- Leads necessary discussions and collaborations to evaluate new or updated health authority regulations specific to China.
- Provides support for complex projects, making timely and effective decisions based on available data to meet project objectives, especially in ambiguous situations.
- Collaborates with other departments and Subject Matter Experts (SMEs) to gather necessary information and data for regulatory submissions.
- Identifies potential regulatory challenges and emerging issues throughout the product lifecycle, developing proactive solutions.
- Contributes to the maintenance of global product registrations, including EU MDR Technical Documentation and Global Submission Summary Documents.
- Participates in the preparation for and execution of internal and external regulatory audits.
- Assembles materials required for new global product submissions, license renewals, and modification submissions.
- Requests, acquires, and maintains FDA Certificates to Foreign Government (CFGs), including notarization and legalization, as well as EC/ISO certificates and other regulatory documents.
- Initiates investigations into non-conformances driven by translation vendors and oversees CAPA/SCAR investigations.
Qualifications:
- Bachelor's degree in a relevant field
- 3-5 years of direct experience in regulatory affairs within the medical device sector
- Familiarity with multiple regulatory jurisdictions, including EU, US, and Asia, particularly in labeling and regulatory submissions.
- Experience with EU MDR technical documentation
- Proven ability to manage tasks or projects, with basic project management skills.
- Regulatory Affairs Certification is preferred but not mandatory.