Regulatory Lead (100% Remote)

***Please note that our customer is currently not considering applicants from the following locations: Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.***

Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic-assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with the top medical professionals, they continue to develop new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world.

We are seeking a Regulatory Lead on a contract basis to support our Customer's business needs. This role is 100% remote, but can be a hybrid setup for candidates local to Sunnyvale, CA.

The Regulatory Lead serves as the primary regulatory representative and Subject Matter Expert (SME) within the functional group. This role partners with cross-functional organizations and global regulatory counterparts to support product lifecycle management, including ongoing product changes and continuous improvement initiatives. The Regulatory Lead will act as the regulatory expert on assigned product groups, ensuring compliance with applicable standards, emerging regulations, and industry expectations.

Responsibilities:

• Provide regulatory guidance and direction, including risk assessments and creative, risk-based solutions, to business partners and leadership.
• Develop and recommend regulatory strategies for new product development and product changes, including design, materials, labeling, packaging, manufacturing processes, and facilities.
• Support engineering and manufacturing teams on regulatory issues, reviewing design input, risk management, and test documentation.
• Assess the impact of product and process changes, determining the appropriate regulatory pathway for U.S. and EU markets.
• Lead, plan, and prepare U.S. regulatory submissions, including FDA 510(k) premarket notifications and internal “Letters to File.”
• Act as the regulatory liaison between cross-functional teams and international counterparts to coordinate global submissions, approvals, and rollouts.
• Provide strategic, risk-based input on projects and facilitate alignment across teams.
• Deliver training and mentorship to RA colleagues and cross-functional partners on regulatory requirements and best practices.
• Monitor emerging regulations, industry perspectives, and guidance documents relevant to the product group.
• Perform additional duties as required to support regulatory and business objectives.

Skills and Qualifications:

• Bachelor’s degree in Biomedical, Electrical, or Mechanical Engineering, or Pharmacy preferred. Equivalent experience in complex medical devices may be considered.
• 10+ years in the medical device industry with progressive responsibility.
• 5+ years in regulatory affairs with proven experience in U.S. submissions and EU technical documentation.
• Strong understanding of U.S. and EU medical device regulations.
• Expertise in design controls, risk management, verification and validation, and labeling requirements.
• Experience with complex products integrating mechanical, electrical, and software elements is a plus.
• Excellent communication skills, with proven ability to translate technical documentation into regulatory submissions.
• Strong interpersonal, influencing, and negotiation skills.
• Ability to manage multiple projects in fast-paced environments, balancing detail with strategic perspective.
• Team player with a proactive, collaborative mindset.
• RAPS Regulatory Affairs Certification (RAC) preferred.

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

Contractor benefits are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements) Benefits include: Medical, Dental, Vision, 401k.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.