Principal, Regulatory Affairs, East Coast Preferred

About the role

The Principal, Regulatory Affairs is an experienced individual contributor responsible for supporting regulatory strategy and execution across the medical device product lifecycle. This role partners closely with Quality, R&D, Operations, Commercial, and other functions to understand business needs, solve problems, assess regulatory risks, and develop practical solutions. The successful candidate will bring strong critical thinking, business acumen, customer focus, and the ability to work independently and influence cross-functional stakeholders.

Responsibilities

• Develop and support regulatory strategies for new products, product changes, registrations, and lifecycle activities.
• Provide regulatory guidance to cross-functional teams, balancing regulatory requirements, risk, business needs, and timelines.
• Apply critical thinking and sound judgment to complex issues, identify options, and recommend practical solutions.
• Build strong relationships with R&D, Quality, Operations, Commercial, Marketing, and other stakeholders to understand their needs and provide responsive regulatory support.
• Author and support FDA 510(k) submissions, Pre-Submissions, Letters to File, and other regulatory documentation.
• Support EU MDR technical documentation, submissions, and interactions with Notified Bodies.
• Assess regulatory impact of product, design, manufacturing, labeling, and process changes.
• Support global registrations and regulatory documentation requirements, including MDSAP markets as applicable.
• Maintain regulatory information and databases, including GUDID, EUDAMED, and GS1.
• Manage multiple projects and priorities, proactively communicating status, risks, and issues.
• Identify opportunities to improve regulatory processes, responsiveness, and cross-functional ways of working.
• Provide guidance and mentorship to other team members as appropriate.

Qualifications

• Bachelor’s degree or higher in a scientific, engineering, regulatory, or related discipline (or equivalent experience).
• 5+ years of relevant Regulatory Affairs experience preferred, ideally within the medical device industry.
• Experience with FDA and EU medical device regulatory requirements and submissions.
• Strong critical-thinking and problem-solving skills with the ability to work through complex or ambiguous issues.
• Strong business acumen and ability to understand how regulatory decisions affect different functions and business priorities.
• Ability to work independently, exercise sound judgment, and take ownership of issues through resolution.
• Strong stakeholder-management skills and ability to build effective cross-functional relationships.
• Customer-focused and solutions-oriented approach with a sense of urgency and responsiveness.
• Ability to influence without direct authority and work effectively with stakeholders with different priorities.
• Strong written and verbal communication skills, including the ability to simplify complex regulatory topics.
• Strong project-management and organizational skills with the ability to manage multiple priorities.
• Knowledge of FDA, EU MDR, and global medical device regulatory requirements.
• Experience with regulatory databases and document management systems preferred.
• Applicants must be authorized to work for ANY employer in the US; sponsorship of employment visas is not available.

Benefits

• Medical
• 401K
• Vacation and sick time
• Paternal leave
• Other benefits

Pay

A reasonable estimate of the current pay range for this role is $100,000 - $135,000/annual. Further, pay is offered based on geographic location, internal equity, market data, applicant’s job-related skills, commensurate experience, required licensures, certifications, and certain degrees.