In this position, you will collaborate with the team responsible for securing global approvals for Penumbra products, helping bring our life‑saving technologies to patients worldwide. You will handle research, preparation, coordination, submission, and upkeep of documentation packages for new products and updates to existing ones, ensuring compliance with regulatory requirements. The Regulatory Affairs Specialist APAC will support regulatory compliance and help improve quality system procedures.

What You’ll Work On
• Prepare complex submissions under supervision to obtain commercial distribution approvals in assigned countries.
• Communicate with regulatory authorities, consultants, and distributors as needed to support product registration.
• Carry out submission‑related tasks such as research, identifying filing requirements, correspondence, scheduling, tracking, trend analysis, translation assistance, filing preparation, and document maintenance to meet U.S. and international regulations.
• Monitor and maintain current product registrations, ensuring updates are made as required.
• Review and approve advertising and promotional materials to ensure they meet regulatory standards.
• Review and approve product and manufacturing changes, as well as shipping release documents, for regulatory compliance.
• Interpret region‑specific regulations and guidelines to support organizational goals, stay current on regulatory requirements in existing markets, and proactively identify needs in new markets.
• Assist with customs and import procedures to support timely product movement.
• Work with cross‑functional teams to ensure regulatory strategies are compliant, aligned with business goals, and integrated into the appropriate development phases.
• Support activities related to Field Corrective Actions, including execution and documentation.
• Participate in internal and external audits, and help monitor and track open non‑conformances and observations.

What You Contribute
• Bachelor’s degree in a scientific or related field, plus 3+ years of relevant regulatory experience in the medical device or related industry, or an equivalent combination of education and experience.
• Working knowledge of quality systems and ISO 13485, GDPMD (S), biocompatibility requirements, and regulatory procedures needed for medical device submissions and country‑specific registrations.
• Proven experience preparing, submitting, and updating domestic and international regulatory submissions using appropriate technical standards and principles.
• Strong English communication skills, both written and verbal.
• High attention to detail and accuracy.
• Proficiency in MS Word, Excel, and PowerPoint.
• Strong organizational skills with the ability to prioritize and manage multiple projects at once.
• Ability to suggest solutions and make regulatory decisions that support business needs.

Working Conditions
Office‑based environment. Must be willing and able to work on‑site if needed. May require up to 20% travel. Role may involve lifting and moving up to 25 pounds. Must be able to move between buildings and floors, remain seated and use a computer or standard office equipment for extended periods, read and create documents and emails, access office supplies or files, and communicate effectively with employees at all levels.

Penumbra, Inc., based in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets unique products across a wide portfolio that addresses complex medical conditions in areas with high unmet need. The company sells its products to hospitals and healthcare providers through direct sales in the U.S., much of Europe, Canada, and Australia, and through distributors in select global markets. The Penumbra logo is a trademark of Penumbra, Inc.

Qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by law.

If you live in California, please review Penumbra’s Privacy Notice for California Residents.

For more information about Penumbra’s commitment to equal opportunity, please refer to the appropriate resources.