Job Description

We are seeking an experienced Regulatory Affairs Consultant with strong global Outside United States (OUS) regulatory expertise to support Class III implantable medical device programs. This consultant will provide strategic and operational regulatory support for international market registrations, submissions, and regulatory compliance activities, with a primary focus on the European Union and additional support for Japan, China, and Brazil.

The ideal candidate will have hands-on experience navigating complex regulatory pathways for high-risk implantable products and the ability to work cross-functionally with quality, clinical, engineering, and product development teams. Experience supporting CNS-related products, subcutaneous injection systems, and/or combination products is highly preferred.

Responsibilities

• Lead and support OUS regulatory strategy and execution for Class III implantable medical devices.
• Lead and support OUS regulatory strategy and execution for Class III implantable medical devices.
• Prepare, review, and manage international regulatory submissions and registrations for global markets, including:
• European Union (MDR)
• Japan (PMDA/MHLW)
• China (NMPA)
• Brazil (ANVISA)
• Provide regulatory guidance throughout the product lifecycle, including development, design changes, labeling updates, and post-market activities.
• Assess regulatory requirements and submission pathways for new and existing products in international markets.
• Collaborate cross-functionally with R&D, Clinical, Quality, Manufacturing, and Marketing teams to support global regulatory objectives.
• Interface with notified bodies, regulatory authorities, international agents, and external partners as needed.
• Support technical documentation reviews and ensure alignment with applicable international regulations and standards.
• Provide regulatory risk assessments and strategic recommendations for market expansion activities.
• Monitor evolving global regulatory requirements and communicate impacts to internal stakeholders.
• Support responses to regulatory authority questions, deficiencies, and submission remediation activities.
• Contribute to regulatory planning, timelines, and submission execution for international product launches.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related discipline. Advanced degree preferred.
• 8+ years of regulatory affairs experience within the medical device industry.
• Strong hands-on OUS regulatory experience supporting Class III implantable medical devices.
• Required experience with EU MDR submissions and regulatory strategy.
• Strongly preferred experience supporting:
• Japan PMDA/MHLW submissions
• China NMPA submissions
• Brazil ANVISA registrations
• Experience interacting directly with notified bodies and international regulatory agencies.
• Knowledge of global regulatory requirements for high-risk implantable devices.
• CNS product experience and/or subcutaneous injection device experience strongly preferred.
• Combination products regulatory experience is a plus.
• Strong understanding of design controls, risk management, clinical evaluation, and technical documentation requirements.
• Excellent communication, project management, and stakeholder collaboration skills.
• Ability to work independently in a fast-paced consulting environment.
• Neuromodulation, CNS, implantable, or drug-device combination product experience preferred.
• Experience supporting global product commercialization and international market expansion initiatives.
• Familiarity with ISO 13485, ISO 14971, EU MDR, and applicable international standards/regulations.

Location

• Remote

Employment Type

• Consulting

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp-to-permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com

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