Senior or Principal, Regulatory Affairs, East Coast Preferred

Senior or Principal, Regulatory Affairs, East Coast Preferred

Location of Work Remote, US

Employment Type Full Time Employee

Job Description

Our mission

At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience. We are here to support you every step of the way.

Our brand promise

We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.

• Remarkable service: A seamless, personal process designed around you and your needs.

• Trusted performance: Our product family is the result of years of experience championing surgeons and listening to their expertise.

• Outstanding value: No matter the surgical specialty, we deliver quality products for all markets.

Our people promise

Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.

Job Purpose Summary

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.

What you will do

• 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.

What you will need

• 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.

• In order to qualify for this position, applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time.

What we value

• Customer First - We deliver extraordinary experiences.

• Accountability - We do what we say.

• Integrity - We do what is right.

• Inspired - We love what we do.

• One Global Team -We before me, always.

Join us today and Excel@Corza !

Corza Medical offers a competitive benefits package including medical, 401K, vacation and sick time, paternal leave and other benefits.

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.

Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics.

Notice To Third Party Agencies:

Corza does not accept unsolicited resumes from recruiters, employment agencies, or other staffing services. Any unsolicited resumes, including those submitted to hiring managers or other business leaders, will become the property of Corza Medical and Corza Medical will have the right to hire that candidate without reservation – no fee or other compensation will be owed or paid to the recruiter, employment agency, or other staffing service.