Bachelor's Degree or equivalent experience in a scientific, engineering or related technical discipline
7+ years of experience with increasing responsibility within regulatory, quality, and design assurance in the medical technology/device industry
3+ years of management experience
Expertise in 510K, PMA, and medical device submissions
Strong written and verbal communication skills, particularly in regulatory contexts
Responsibilities
Provide strategic Regulatory and Quality guidance to executive leadership and internal stakeholders
Collaborate with executive management in organizational planning and governance procedures
Interpret and communicate evolving regulatory requirements and business impacts
Manage the international registration process and maintain product compliance globally
Ensure compliance with FDA QSR, ISO 13485 and EU MDR requirements
Drive regulatory and quality process improvements
Develop a high-performing team to support regulatory and design assurance needs
Benefits
Health, Dental, Vision insurance coverage
401k with employer match
Flexible work arrangements
Voluntary benefits to meet your individual needs
Full Job Description
Benefits of working at Nonin:
Health, Dental, Vision insurance coverage
401k with employer match
Flexible work arrangements
Voluntary benefits to meet your individual needs
Essential Job Functions:
Provide strategic Regulatory and Quality guidance to executive leadership and internal stakeholders.
Collaborate with executive management in determining departmental organizational plan, operating model, strategy deployment, and governance procedures.
Interpret evolving regulatory requirements and communicate business impacts
Maintain product registrations and regulatory compliance across global markets.
Manage the international registration process, organization, and maintenance of current registrations as well as future strategic planning of global submissions.
Ensure company products and operations comply with applicable regulatory standard requirements including FDA QSR, ISO 13485 and EU MDR requirements with emphasis on regulatory and design quality requirements.
Drive regulatory, design quality, and product development process improvements using continuous improvement approaches.
Participate in project teams to provide regulatory and design assurance leadership and input.
Facilitate achievement of business objectives using risk-based approach while ensuring quality and regulatory compliance.
Enable compliant, efficient, and risk-based execution of clinical affairs processes, and product verification and validation.
Develop and grow a high-performing team to support regulatory and design assurance organizational needs; facilitate organizational cohesiveness with the Nonin operating model, business strategy and culture of regulatory/design assurance compliance.
Lead efforts in support of Nonin QMS and compliance remediation activities.
Drive new product development quality strategy including identification of applicable standards, design verification testing, and human factors engineering.
Develop and lead strategic relationships with third party contract research organizations and testing service providers.
Facilitate and support audits by applicable regulatory agencies including FDA, EU notified body, and customers.
Required Education & Experience:
Bachelor's Degree or equivalent experience in a scientific, engineering or related technical discipline
7+ years of experience with increasing responsibility within regulatory, quality, and design assurance in the medical technology/device industry
3+ years of management experience
Required Knowledge, Skills & Abilities:
Expertise in 510K, PMA, Medical device, Software as a medical device and non-medical device (SaMD), combination products, or digital health technologies
Expertise with global regulatory submissions outside of the United States and Europe
Knowledge of applicable regulations in the areas of the FDA QSR, ISO 13485 and EU MDR/MDD, Design Controls.
Experience supporting new product development concept through commercialization.
Strong written and verbal communication skills, especially when dealing with regulatory agencies or certification bodies
Ability to explain and resolve differences in interpretation of standards, regulations and quality system and design quality requirements.
Demonstrated experience in development, deployment and execution of quality and compliance strategy.
