Quality and Regulatory Manager

Nonin Medical, Inc.; Minneapolis (MN); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

401k with employer match

Voluntary benefits

Job summary

Nonin Medical in Minneapolis, MN is seeking a strategic Regulatory and Design Assurance leader to guide regulatory and quality initiatives across the organization. The role directs global submissions, ensures compliance with FDA QSR, ISO 13485, and EU MDR, and leads a high-performing team to support product development and lifecycle management.

You will collaborate with executive leadership to shape governance, drive continuous improvement, and manage international registrations, with emphasis

Qualifications

• 7+ years of regulatory, quality and design assurance in medical technology
• 3+ years of management experience
• Bachelor’s degree or equivalent in a scientific/engineering discipline

Responsibilities

• Provide strategic Regulatory and Quality guidance to executive leadership and internal stakeholders.
• Collaborate on departmental organizational plans, operating model, strategy deployment, and governance.
• Maintain product registrations and regulatory compliance across global markets and lead international registrations.
• Ensure compliance with FDA QSR, ISO 13485 and EU MDR requirements with emphasis on design quality.
• Drive quality and design assurance process improvements and support audits by regulatory bodies.

Skills

Regulatory strategy

Quality systems

FDA QSR

EU MDR

Global submissions

Leadership

Communication

Education

Bachelors degree in science/engineering

Tools

Regulatory submissions software

Job description

Nonin
13700 1st Ave N
Minneapolis, MN 55441, USA

You can count on Nonin. Our vision is to improve people’s lives by creating noninvasive medical devices people can count on. Nonin’s culture is grounded in our mission, and we live by our cultural tenets of courage, ownership, and agility. The courage to challenge assumptions and take risks, the ownership to act with accountability, and the agility to constantly innovate and move with speed. It is these tenants that have made Nonin the technology leader for over 40 years. As a privately owned company, you are not one among many, but an important part of our success with the ability to learn, grow and impact all aspects of the business. So, if you are looking for a smaller company to spread your wings while making big company impacts, join Nonin today… Together we will improve lives around the world, including your own.

Benefits of working at Nonin

• 401k with employer match
• 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.

Physical Requirements

• Sit, and/or stand 8 hrs/day.

Nonin Medicalis an Equal Opportunity/Affirmative Action Employer - Disabled/Veteran. To request a copy of our Aff… call us at 1-800-356-8874 and ask for a human resources representative.

It is the policy of Nonin Medical that all offers of employment made shall be contingent upon successful completion of electronic background check(s). These checks will be job-related, consistent with business necessity, and conducted by our vendor pursuant to all applicable laws, rules, policies, and procedures of our candidates' specific locale.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.