Regulatory Affairs Specialist – APAC

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November 25

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Penumbra, Inc.

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Healthcare Insurance • Biotechnology • Medical Devices

Penumbra, Inc. is a global healthcare company focused on developing innovative technologies to help patients worldwide. Specializing in the production of medical devices for neuro and vascular conditions, Penumbra offers products such as thrombectomy devices, embolization catheters, and MRI-compatible systems. The company is dedicated to advancing patient care with next-generation software solutions like Lightning Flash 2. 0, designed for the rapid removal of blood clots and treatment of pulmonary embolism. Penumbra is committed to improving outcomes for conditions like stroke, brain aneurysm, and heart attack, supported by clinical evidence and investor growth strategies.

1001 - 5000 employees

Founded 2004

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

• Prepare complex submissions with supervision to gain approvals for commercial distribution for countries in their sphere of responsibility. • Communicate with regulatory authorities, regulatory consultants, and distributors to facilitate registration as deemed necessary. • Perform the following activities in support of submissions: research, identification of filing regulations, correspondence, scheduling, tracking, trending analysis, translation support, filing preparation and document maintenance for compliance with U.S. and international regulatory requirements. • Track and ensure that existing product registrations are maintained and updated as required. • Review and approve advertising/promotional materials and procedures to ensure regulatory compliance. • Review and approve product and manufacturing changes and shipping release documents for compliance with applicable regulations. • Provide interpretation of region-specific Regulatory Authority regulations and guidelines as needed to support accomplishment of organizational objectives. Maintain up-to-date understanding of current and new regulatory requirements in existing markets and proactively identify regulatory requirements in prospective markets. • Assist with Customs/Importation procedures to ensure timely movement of product. • Partner with cross-functional team members to ensure that regulatory strategies are compliant, aligned with business objectives, and incorporated into the appropriate product development project phases. • Assist in activities (e.g., execution, documentation) related to Field Corrective Actions. • Participate in internal and external audits, including the monitoring and tracking of open non-conformances and observations.

🎯 Requirements

• A Bachelor's degree in a scientific discipline or related field with 3+ years of relevant regulatory experience in medical device or related industry, or equivalent combination of education and experience. • Working knowledge of quality systems and ISO 13485, GDPMD (S), biocompatibility requirements and regulations, procedures and practices required by regulatory bodies for medical device industry activities such as filing and/or creation of premarket submission dossiers and other country specific product registrations. • Demonstrated success creating, submitting, and making changes to domestic and international regulatory submissions, applying appropriate technical standards, principles, theories, concepts, and techniques • Strong oral, written, and interpersonal communication skills in English. • High degree of accuracy and attention to detail. • Proficiency with MS Word, Excel, and PowerPoint • Excellent organizational skills with the ability to prioritize assignments while handling various projects simultaneously. • Ability to propose solutions and make regulatory decisions for the business.

🏖️ Benefits

• Willingness and ability to work on site if required • May have business travel from 0% - 20%