This role ensures that design control and risk management activities for software and digital medical products (SaMD, SiMD) meet all required procedures, standards, and regulations. The position provides leadership at the project level, guiding quality and compliance in areas like development, cybersecurity, verification/validation, and maintenance.

Key Responsibilities:

Manage and review design and risk documentation throughout the product lifecycle.

Advise teams on software compliance, including cybersecurity and privacy.

Ensure product quality and documentation meet standards before approval.

Support product development and design changes.

Handle audit-related quality topics and corrective actions.

Interpret and apply regulations to create defensible documentation.

Offer guidance on tools and techniques for development and investigation.

Participate in product requirement definition and failure analysis.

Collaborate cross-functionally (e.g., with R&D, Marketing, Regulatory) to drive CAPAs.

Potentially supervise others and lead quality-focused projects.

Identify and correct compliance gaps.

Lead quality system improvement initiatives and support audits.

Collaboration:

The role involves close collaboration across QA/RA, R&D, Marketing, Service, and other internal teams. Strong communication, interpretation of quality standards, and influence in driving compliance improvements are essential.

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .

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Skills and Requirements

Bachelors degree with 12+ years of relevant experience or Masters degree with 9+ years or equivalent experience.

Software engineering platforms and cloud-based applications.

Project design, validation, quality planning, and risk management (including human factors and cybersecurity).

Regulatory submissions, complaint systems, and reporting to authorities.

Solid knowledge of medical device regulations (e.g., FDA QSR, EU MDR) and standards (e.g., ISO 13485, ISO 14971, IEC 62304, IEC 62366, AAMI TIR57).

Deep understanding of quality/regulatory standards for SaMD and SiMD.

Proven ability to apply regulatory requirements to data, risk, and design decisions using a risk-based approach. - Experience with AI/ML models.

Familiarity with international regulatory landscapes beyond FDA and EU MDR.

Demonstrated judgment in aligning compliance with business objectives. null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.