Senior Regulatory Affairs Specialist

Intuitive•Sunnyvale, CA

About The Position

The Sr. Regulatory Affairs Specialist's primary responsibilities include developing regulatory plans, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses. The Sr. Regulatory Affairs Specialist will provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation. They will determine regulatory pathways and formulate regulatory strategies for the U.S. and Canadian markets. They will assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes, and influence and lead global regulatory strategies. The role involves authoring and leading regulatory documentation and submissions, including U.S. FDA 510(k) premarket notifications, internal Letters to File, pre-submissions, and Health Canada submissions with minimal supervision. The specialist will coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals. They will provide risk-based guidance and regulatory input to projects and issues, ensuring cross-functional alignment and resolution. Additionally, they will collaborate with international counterparts to support global regulatory submissions, approvals, and implementation rollouts.

Requirements

Minimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science)
In-depth understanding of US Medical Device regulations, Health Canada guidance and EU MDR.
Regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirement
Ability to work in a fast-paced environment and handle multiple projects simultaneously
Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions
Team player who seeks to help and learn from colleagues seeing the department success as their own
Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
Proactively seeks to develop and become well-versed within the regulatory landscape.

Nice To Haves

RAPS Regulatory Affairs Certification (RAC) is a plus.

Responsibilities

Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.
Determine regulatory pathways and formulate regulatory strategies for the U.S. and Canadian markets.
Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes.
Influence and lead global regulatory strategies.
Author and lead regulatory documentation and submissions, including U.S. FDA 510(k) premarket notifications, internal Letters to File, pre-submissions, Health Canada submissions with minimal supervision.
Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals.
Provide risk-based guidance and regulatory input to projects and issues, ensuring cross-functional alignment and resolution.
Collaborate with international counterparts to support global regulatory submissions, approvals, and implementation rollouts.