Regulatory Affairs Specialist II – Global Markets

Regulatory Affairs Specialist II – Global Markets

Location: Irvine, CA

Role Summary

The Regulatory Affairs Specialist II is responsible for preparing, submitting, and maintaining regulatory filings to support first‑wave market entry for our medical device portfolio (needles and related products). This role focuses on global registrations and technical documentation for priority markets and subsequent markets. Will need to work cross‑functionally with Quality, R&D, Vendors, and Operations.

Key Responsibilities

• Plan, prepare, and submit regulatory applications and technical documentation to support first‑wave market registrations in priority countries and regions (e.g., United States, Canada, European Union under MDR, Japan, Australia, Brazil, China). Multiple market filings in other regions will also be part of the maintenance of portofolios.
• Maintain and update technical files and design dossiers in accordance with applicable regulations (e.g., EU MDR, 21 CFR 820, ISO 13485) and internal procedures.
• Coordinate responses to regulatory authority questions and deficiency letters in collaboration with internal subject matter experts and external partners.
• Support global product lifecycle activities, including renewals, labeling updates, and change assessments, ensuring ongoing compliance in assigned markets.
• Monitor global regulatory requirements and guidance for assigned markets, summarize relevant changes, and communicate impact and recommended actions to internal stakeholders.
• Partner with cross‑functional teams (R&D, Quality, Manufacturing, Vendors, Marketing) to ensure regulatory requirements are considered in design control, risk management, labeling, and claims.
• Contribute to the development and continuous improvement of regulatory processes, templates, and tools to support efficient global submissions.
• Support audit and inspection readiness by providing regulatory documentation and explanation of submission strategies, where needed.

Required Qualifications

• Bachelor’s degree in life science, engineering, pharmacy, or related discipline.
• Approximately 5 years of regulatory affairs experience in the medical device industry (or a combination of device and combination products), with hands‑on experience preparing and managing regulatory submissions for multiple international markets.
• Demonstrated experience with global registrations and product approvals in at least several of the following markets: US, Canada, EU/MDR, Japan, Australia, Brazil, China.
• Working knowledge of technical files/design dossiers, including structure and content requirements, and experience compiling and maintaining these in alignment with applicable standards and regulations.
• Solid understanding of medical device regulatory frameworks, such as FDA 21 CFR 820, EU MDR 2017/745, ISO 13485, and relevant guidances/standards.
• Strong analytical, organizational, and project‑management skills, with the ability to manage multiple submissions and timelines across markets.
• Excellent written and verbal communication skills, with the ability to summarize complex technical and regulatory information clearly.

Preferred Qualifications

• Prior experience with Class II / III medical devices, needles, or other minimally invasive devices.
• Experience supporting clinical trial or post‑market study submissions and associated regulatory interactions in at least one major market.
• Language skills: proficiency in Japanese, Mandarin, or Korean is strongly preferred, given our target markets and collaboration with regional partners.
• Experience working with global regulatory consultants, country representatives, or distributors to obtain and maintain registrations.
• Experience working in a fast‑paced, growth‑stage or startup environment, with comfort operating independently and building processes as the company scales.

Job Type: Full-time

Pay: $90,000.00 - $125,000.00 per year

Work Location: In person

Salary : $90,000 - $125,000