Director, Regulatory Affairs – Americas

This is a fully remote position, open to applicants in Texas.

📋 Description

• Formulate and execute regulatory strategies for the Americas that align with global business goals and product development initiatives.

• Oversee and assist in regulatory submissions and interactions with agencies, including FDA IDE, pre-submissions, Q-submissions, 510(k), De Novo, breakthrough designation, and various approval pathways.

• Keep submission records and certificates of registration organized within a regulatory database.

• Directly communicate with the FDA and other regional regulatory bodies, representing the company during meetings, inspections, and audits.

• Offer regulatory advice to Quality, R&D, Clinical, and other teams on design control, risk management, testing, clinical evidence, production, and post-market activities.

• Collaborate with product development and commercial opportunity teams on protocols, reports, technical documentation, and submission materials.

• Evaluate regulatory requirements and market entry implications for new business ventures and externally sourced products.

• Lead significant regulatory initiatives, including the MiYOSMART US clinical and IDE program.

• Assist teams in addressing evidence, testing, risk management, and documentation deficiencies.

• Engage and oversee external contractors, consultants, and advisors.

• Manage or assist with FDA and other authority reporting, including Medical Device Reports, vigilance reports, and post-market reporting.

• Develop, review, and authorize compliant labeling, IFUs, product claims, promotional materials, and regulatory documentation.

• Ensure Unique Device Identification labeling and registration within UDI databases.

• Enhance regional and global regulatory operations through improved processes, tools, workflows, and governance.

• Track regulatory intelligence and interpret shifts in international regulations.

• Evaluate design and manufacturing modifications for compliance with regulations, FDA guidance, and ISO, ANSI, and IEC standards.

• Deliver cross-functional training and insights on regulatory requirements.

• Provide guidance on packaging regulations, environmental and chemical substance restrictions, PFAS, and related product compliance mandates.

• Oversee monthly reporting, budget planning and monitoring, as well as regulatory vendor or consultant management.

⛳️ Requirements

• A Bachelor’s degree in a scientific discipline, preferably in engineering, life sciences, or a regulatory field.

• Over 10 years of experience in Regulatory Affairs within the Medical Device sector.

• A minimum of 5 years of managerial experience.

• Proven capability to define and implement FDA regulatory strategies and submissions for medical devices, including pre-submissions, Q-submissions, 510(k), De Novo, and other approval pathways.

• Previous direct experience with the FDA and other regulatory agencies.

• Active involvement in regulatory or quality associations that provide up-to-date regulatory and compliance knowledge.

• Experience collaborating with external legal, quality, regulatory, or clinical consultants, both domestically and internationally.

• Familiarity with broader product compliance issues, such as packaging, chemical substance restrictions, PFAS, or environmental compliance.

• Extensive understanding of ISO 13485, ISO 14971, and 21 CFR 820 Quality Management System Regulations.

• Knowledge of US FDA medical device regulations, Canadian MDR, LATAM requirements including INVIMA, ANMAT, ISP, COFEPRIS, and ANVISA, and other relevant Americas regulations.

• Experience with international standards and applicable FDA guidance.

• Proficient in design control, risk management, design development processes, and technical documentation for regulatory submissions.

• Strong project management and change management capabilities.

• Exceptional organizational skills and meticulous attention to detail.

• Excellent English communication skills, both verbal and written.

• Willingness to work collaboratively with international colleagues.

• Availability to travel occasionally, both domestically and internationally, expected to be less than 10% of the time.

🏝️ Benefits

• Flexible remote work arrangement.

• Limited domestic and international travel anticipated, expected to be less than 10% of the time.