Senior Regulatory Affairs Specialist

Eastridge Workforce Solutions, in collaboration with a leading innovator in neurovascular device technology, is seeking an experienced Senior Regulatory Specialist to join the team. This individual will play a pivotal role in overseeing global product registrations, leading regulatory submissions, and ensuring compliance with relevant regulations and standards. Apply now to become a vital part of our regulatory team!

Summary

The Senior Regulatory Specialist will be responsible for planning, directing, and coordinating global product registrations, leading regulatory submissions planning and execution, and collaborating with cross-functional teams to drive timely and accurate submission development.

Duties and Responsibilities:

• Manage and coordinate international product registration submissions, ensuring compliance with regulations and standards.
• Lead regulatory efforts for global product registrations to support business growth and geographical expansion.
• Engage with cross-functional teams to provide regulatory guidance and support planned product launches and market expansion.
• Coordinate submissions and approval of all applications, ensuring accuracy and appropriateness to regional requirements.
• Plan and track product registration and renewal activity, managing expirations, renewals, and new applications.
• Oversee relationships and interactions with Health Authorities to ensure up-to-date regulatory intelligence is shared company-wide.
• Participate in relevant regulatory improvement projects and other duties as required.

Qualifications:

• Bachelor’s degree or higher in Life Sciences, Engineering, or related disciplines.
• Minimum of 5 years' experience in Regulatory Affairs with Class I, II, and III medical devices.
• Deep understanding of relevant laws, regulations, and guidelines governing medical device development, approval, and marketing.
• Proven experience with international documents and registrations for various regions.
• Strong knowledge of EU (MDD/MDR) medical device regulations and submissions.
• Experience in preparing US regulatory submissions (e.g., IDE, 510(k), PMA) and technical documentation.
• Familiarity with Quality Systems requirements such as QSR, ISO 13485, GxP.
• Strong leadership, project management, and problem-solving skills.
• Ability to identify compliance risks and escalate when necessary.
• Demonstrated ability to stay current with changing regulations and standards.
• Excellent computer aptitude and document formatting skills.

Benefits:

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Disability insurance

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

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