Regulatory Software Assurance Specialist

Job Description

Job Description

Job Title: Regulatory Software Assurance Specialist (Quality Focused)

Job Description

The Regulatory Software Assurance Specialist administratively supports, governs, coordinates, and continuously improves software compliance activities across product development, production, and quality systems. This role ensures that software used in regulated environments meets FDA and global regulatory expectations through risk-based Computer Software Assurance (CSA) approaches and provides support for software regulatory submission projects. The specialist exercises discretion and independent judgment in matters related to the quality management system and adverse event considerations within a medical device environment.

Responsibilities

• Maintain Computer Software Assurance (CSA) frameworks aligned with FDA guidance, ISO standards, and applicable medical device regulations.
• Drive improvements to CSA documentation workflows, templates, and knowledge repositories to enhance consistency, efficiency, and standardization.
• Support risk assessment activities by gathering relevant data, preparing documentation, and actively participating in team discussions.
• Author and review validation and assurance documentation to ensure accuracy, completeness, and regulatory compliance.
• Collaborate with cross-functional teams to help implement and monitor compliance of quality and production software systems used in medical device environments.
• Contribute to cross-functional process optimization initiatives by applying CSA principles to streamline validation, change control, and system implementation practices.
• Assist in the preparation of validation documents such as test protocols, user requirements, and traceability matrices under appropriate guidance.
• Support compliance activities for software regulatory submission projects, including providing technical support, assisting with requirements gathering, and compiling regulatory documentation under guidance.
• Stay informed on regulatory updates, FDA expectations, and industry trends through ongoing training, self-study, and team briefings.
• Contribute to quality system activities related to validation, document control, CAPA, risk management, and quality engineering in support of medical device quality assurance.

Essential Skills

• 2+ years of experience in medical device manufacturing quality assurance or computer systems validation (CSV).
• Experience working within a quality management system in a regulated medical device environment.
• Knowledge of FDA regulations, including 21 CFR Part 820 and 21 CFR Part 11, and their application to software and quality systems.
• Practical understanding of Computer Software Assurance (CSA) methodologies and validation principles.
• Experience with validation activities, including planning, execution, and documentation of software or computerized systems.
• Familiarity with medical device quality assurance practices, including quality control, quality engineering, and risk management.
• Experience with CAPA processes, document control, and change control within a regulated environment.
• Proficiency with Microsoft Office applications, including strong working knowledge of Word, Excel, and PowerPoint.
• Excellent technical documentation skills, with the ability to write clear, concise, and compliant validation and assurance documentation.
• Strong communication skills, with the ability to collaborate effectively with cross-functional teams in quality, production, and product development.

Additional Skills & Qualifications

• Bachelor of Science degree in Sciences, Engineering, or a related field.
• Experience supporting software regulatory submission projects in a medical device or similarly regulated industry.
• Knowledge of ISO standards relevant to medical device quality systems and software validation.
• Experience with Computer System Validation (CSV) in support of quality and production systems.
• Familiarity with SAP or similar enterprise resource planning (ERP) systems used in quality or manufacturing environments.
• Experience with quality tools and methodologies related to risk management and process optimization.
• Advanced knowledge of Microsoft Excel, including use of functions such as VLOOKUP and working with data tables.
• Advanced knowledge of Microsoft PowerPoint for preparing clear and professional presentations.
• Exposure to computer assurance concepts within medical device quality assurance, including integration of CSA into existing quality processes.

Work Environment

The role operates in a hybrid work environment with approximately 90% of the time spent working from home and the remainder on-site as needed. The position supports product development, production, and quality systems within a regulated medical device setting, focusing on software used in quality and production processes. The specialist frequently uses standard office productivity tools, including Microsoft Office applications such as Word, Excel, and PowerPoint, and may interact with enterprise systems such as SAP. Work involves close collaboration with cross-functional teams in a structured quality management system environment, with an emphasis on documentation, regulatory compliance, and continuous improvement of software assurance practices.

This is a Permanent position based out of Jacksonville, FL.

The pay range for this position is $80000.00 - $90000.00/yr.

Full company benefits, medical, dental, 401k, profit sharing bonus potential

This is a hybrid position in Jacksonville,FL.

This position is anticipated to close on Jun 22, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.