Implant Direct Regulatory Affairs Specialist (Thousand Oaks, CA)

About the role

This position is responsible for planning, preparing, coordinating, and managing global regulatory submissions and registrations for medical devices, including US 510(k), EU technical documentation, and international dossiers. The role represents Regulatory Affairs on cross-functional project teams, provides regulatory strategy, assesses the impact of design and manufacturing changes, and ensures compliance across global markets.

Responsibilities

• Independently plan, prepare, coordinate, track, follow-up, and obtain clearances for medical device submissions including US 510(k), Health Canada licenses, EU technical files, Brazil, Russia, India, China, Japan, and other countries.
• Represent Regulatory Affairs on assigned project teams through all phases of product development, provide regulatory strategy, and assess regulatory impact of changes on existing products.
• Coordinate and prepare document packages for regulatory submissions to the US, EU, and Canada (510(k) Pre-Market Notifications, Product Reports/Supplements, CE Mark, Health Canada).
• Prepare and compile domestic and international product registration submissions, including Pre-Market Notifications, 510(k)s, CE technical files, and international dossiers (Canada, China, Brazil, Australia, Japan, Russia, India, etc.).
• Represent Regulatory Affairs on change controls and provide regulatory assessment.
• Review and approve marketing communication materials.
• Provide guidance on global compliance, such as CE Marking, product registrations, clinical evaluations in accordance with MDD Annex II and Annex VII, ISO 13485, and Canadian CMDCAS.
• Monitor the regulatory and legislative environment and provide impact assessments.
• Provide information and materials for Certificate to Foreign Governments (CFG) and medical device listings for FDA.
• Support external audits (FDA, Notified Body, international regulators, etc.) as requested.
• Participate as assigned as a CAPA owner, team member, or “task” owner.
• Work with project teams and responsible leaders to provide compliance and product registration requirements for design changes and manufacturing process changes.
• Direct communication with regulatory authorities regarding the company’s regulatory filings.
• Remain current on developments in the field, regulatory requirements, and industry trends.
• Create and update departmental standard operating procedures (SOPs).