Eastridge Workforce Solutions
Principal, Regulatory Affairs
Eastridge Workforce Solutions, Aliso Viejo, California, United States, 92656
Overview
Principal Regulatory Affairs Specialist – Location: Southern California (onsite or hybrid). We’re seeking an experienced Regulatory Affairs professional to lead global product submission and compliance activities for Class II/III medical devices in the neuro and peripheral space. This role involves developing worldwide regulatory strategies, overseeing submissions across multiple regions, and serving as the regulatory point of contact for cross-functional teams. The ideal candidate will have a strong command of U.S., EU, and Canadian regulatory frameworks and experience driving complex submission projects from concept through approval.
Key Responsibilities
Lead strategy and execution for global regulatory submissions, with emphasis on U.S., European, and Canadian markets.
Represent Regulatory Affairs on cross-functional project teams, ensuring alignment between regulatory pathways and business objectives.
Identify and interpret regional regulatory requirements and guide teams on best approaches for compliance.
Prepare, review, and submit regulatory documents to support product approvals and lifecycle maintenance.
Communicate with regulatory authorities regarding routine inquiries and documentation requests.
Assess the regulatory impact of engineering, manufacturing, or labeling changes and maintain accurate approval documentation.
Review labeling and marketing materials for compliance with applicable regulations.
Maintain submission archives, correspondence records, and regulatory documentation systems.
Contribute to process improvements, SOP revisions, and training initiatives within the regulatory organization.
Provide mentorship and guidance to junior staff and foster collaboration across global regulatory teams.
Demonstrate integrity and adherence to all applicable laws, regulations, and quality management procedures.
Perform other related duties as assigned.
Qualifications
Bachelor’s degree in a scientific or engineering discipline required; advanced degree preferred.
8+ years of experience in Regulatory Affairs for medical devices, with proven success leading global submissions.
In-depth knowledge of FDA, EU MDR, and Health Canada requirements.
Experience supporting both new product introductions and lifecycle management activities.
Strong organizational, communication, and leadership skills.
Salary: $145,000-150,000
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal
Industries
Staffing and Recruiting
We’re unlocking community knowledge and insights; referrals may increase your chances of interviewing.
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Principal Regulatory Affairs Specialist – Location: Southern California (onsite or hybrid). We’re seeking an experienced Regulatory Affairs professional to lead global product submission and compliance activities for Class II/III medical devices in the neuro and peripheral space. This role involves developing worldwide regulatory strategies, overseeing submissions across multiple regions, and serving as the regulatory point of contact for cross-functional teams. The ideal candidate will have a strong command of U.S., EU, and Canadian regulatory frameworks and experience driving complex submission projects from concept through approval.
Key Responsibilities
Lead strategy and execution for global regulatory submissions, with emphasis on U.S., European, and Canadian markets.
Represent Regulatory Affairs on cross-functional project teams, ensuring alignment between regulatory pathways and business objectives.
Identify and interpret regional regulatory requirements and guide teams on best approaches for compliance.
Prepare, review, and submit regulatory documents to support product approvals and lifecycle maintenance.
Communicate with regulatory authorities regarding routine inquiries and documentation requests.
Assess the regulatory impact of engineering, manufacturing, or labeling changes and maintain accurate approval documentation.
Review labeling and marketing materials for compliance with applicable regulations.
Maintain submission archives, correspondence records, and regulatory documentation systems.
Contribute to process improvements, SOP revisions, and training initiatives within the regulatory organization.
Provide mentorship and guidance to junior staff and foster collaboration across global regulatory teams.
Demonstrate integrity and adherence to all applicable laws, regulations, and quality management procedures.
Perform other related duties as assigned.
Qualifications
Bachelor’s degree in a scientific or engineering discipline required; advanced degree preferred.
8+ years of experience in Regulatory Affairs for medical devices, with proven success leading global submissions.
In-depth knowledge of FDA, EU MDR, and Health Canada requirements.
Experience supporting both new product introductions and lifecycle management activities.
Strong organizational, communication, and leadership skills.
Salary: $145,000-150,000
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal
Industries
Staffing and Recruiting
We’re unlocking community knowledge and insights; referrals may increase your chances of interviewing.
#J-18808-Ljbffr