Regulatory Affairs Director

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee regulatory affairs responsibilities including submissions, registrations, and listings.

• Ensure adherence to relevant medical device regulations based on jurisdiction, guidance, and standards.

• Aid in the development and upkeep of regulatory documentation.

• Support post-market activities.

• Compose, analyze, and refine technical documents to facilitate country-specific regulatory submissions and compile them in accordance with applicable guidance documents, including device submissions in the USA, Europe, and other regions.

• Collaborate with other departments and communicate the necessary submission requirements for regulatory documents.

• Maintain regulatory documentation.

• Update and manage regulatory authorizations, including 510(k)s, medical device licenses, certificates, and CE Technical Files for the EU, among others.

• Ensure appropriate maintenance of registrations, including renewals, device listings, site registrations, modifications, and annual reports.

• Provide support for approvals in additional regions as required.

• Assist in crafting responses to inquiries from regulatory authorities within designated timelines.

• Stay informed about regulatory procedures and shifts in the regulatory landscape.

• Evaluate device-related incidents and complaints for medical device reporting obligations.

• Compile and submit reportable events to the relevant regulatory authorities promptly.

• Manage recalls and field actions as necessary.

• Review and develop product labels and assess promotional materials for compliance with applicable regulations and technical standards.

• Support external regulatory agency audits by offering regulatory insights to minimize the risk of non-compliance findings.

⛳️ Requirements

• Bachelor’s degree in Engineering, Science, or a related scientific field.

• Minimum of 4 years of experience in a medical device setting.

• Familiarity with regulations, standards, and guidelines associated with regulatory affairs.

• Scientific acumen, capable of understanding complex data while maintaining a comprehensive perspective through strong analytical skills.

• Exceptional written and verbal communication abilities, with a talent for listening, articulating, and advocating effectively.

• Proactive, high-performing, results-driven individual with a commitment to managing projects with ethical integrity.

• Proficient in technical systems (e.g., MS Office applications, databases, effective online research).

• Capable of managing multiple projects and meeting deadlines.

• Ability to identify compliance risks and escalate issues as necessary.

• Exhibit both creative and critical thinking capabilities.

🏝️ Benefits

• Medical coverage

• Dental coverage

• 401K retirement plan