Regulatory Affairs Manager

About InVita Healthcare Technologies

InVita Healthcare Technologies is a leading software provider for complex medical, forensics, and community care environments. We build specialized, highly configurable, and integrated systems that support hospitals, blood centers, donation organizations, public health labs, and forensic labs. InVita is the clear leader in the blood, implant, organ procurement, DNA, and Forensic software markets. Our software solutions have built-in compliance safeguards that streamline processes and enable quick and efficient information exchange with better decision making. For more information about our software solutions, please visit invitahealth.com .

Position Summary

We are seeking a hands-on, detail-driven Manager of Regulatory Affairs to lead and execute regulatory strategy and submissions for our Class II SaMD (Software as a Medical Device) portfolio. This individual will be responsible for preparing and managing 510(k) submissions, interacting with FDA and other regulatory bodies, and maintaining regulatory compliance across the product lifecycle.

You will play a pivotal role in both strategic planning and tactical execution, working closely with cross-functional teams in software engineering, quality assurance, compliance, and product management. This is an ideal opportunity for someone who is not only fluent in regulatory requirements but is also ready to roll up their sleeves to get submissions over the finish line.

Key Responsibilities

• Lead the preparation, authoring, and submission of 510(k) regulatory filings for Class II SaMD products.
• Serve as the regulatory point of contact for cross-functional teams including R&D, QA, and Product.
• Interpret and apply FDA regulations (21 CFR Part 820, Part 11), guidance documents, and ISO 13485 to support software product development and maintenance.
• Draft and maintain regulatory documentation, including labeling, risk assessments, and regulatory strategy documents.
• Work with QA to ensure Design History File (DHF) and Technical File completeness and audit readiness.
• Participate in internal and external audits and inspections, including those conducted by FDA or notified bodies.
• Monitor and evaluate changes in the regulatory landscape (e.g., FDA guidance or MDCG) that may impact product compliance.
• Provide tactical support for product development teams to ensure alignment with regulatory requirements from concept to release.
• Own the regulatory lifecycle management, including change assessments, renewals, and annual reporting.
• Assist in developing and maintaining regulatory SOPs and training programs.

Required Qualifications

Preferred Qualifications

Attributes for Success

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions.

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and perform any other job-related duties requested by any person authorized to give instructions or assignments.

This document does not create an employment contract, implied or otherwise, other than an "at-will" relationship.

InVita provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Reporting to : Chief Information Security Officer

Hours of work : Typical hours of work are from 8 : 30 AM until 5 : 30 PM local time Monday through Friday. Additional hours may be necessary as needed. This position is exempt from overtime.

Compensation : $125,000 - $150,000 USD annually (depending on experience).

The pay range for this role is :

125,000 - 150,000 USD per year(Maryland)

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