Senior Manager of Quality and Regulatory

Job Description

Job DescriptionTitle: Senior Manager of Quality and Regulatory
Location: Plymouth, MN
Job Type: Permanent
Compensation: $170,000 - $180,000 + Bonus
Industry: Medical Device and Healthcare Technology

---
About the Role
We are partnering with a well-established medical device company based in Plymouth, MN to identify a Senior Manager of Quality & Regulatory. Our client is an innovative organization that designs and manufactures advanced medical devices used in clinical and patient care settings around the world. This is an exciting opportunity to join a mission-driven company where quality, compliance, and product innovation directly impact patient outcomes. Job Description
The Senior Manager of Quality & Regulatory will provide leadership for Quality Systems, Design Assurance, and Regulatory Affairs across the organization. Reporting to executive leadership, this individual will balance strategic thinking with operational executionensuring compliance with global medical device regulations while enabling business growth and product innovation.
The ideal candidate is a collaborative and influential leader who can effectively partner across departments, provide objective guidance, and confidently address compliance risks and quality concernseven when delivering difficult messages. This individual will lead a high-performing team while driving continuous improvement and regulatory excellence throughout the organization.
Key Responsibilities
Quality Leadership

• Lead and oversee the Quality Systems function to ensure compliance with FDA, ISO 13485, MDSAP, and other applicable regulatory requirements.
• Drive continuous improvement initiatives related to quality processes, procedures, and systems.
• Ensure inspection readiness and lead activities related to internal audits, external audits, and regulatory inspections.
• Partner with cross-functional teams to identify, assess, and mitigate quality risks.
• Monitor quality performance metrics and implement corrective and preventive actions as needed.

Design Assurance

• Lead Design Assurance activities throughout the product lifecycle, ensuring compliance with design control requirements and regulatory expectations.
• Partner closely with Engineering, R&D, Manufacturing, and Product Management teams to support new product development and sustaining engineering efforts.
• Provide quality oversight for risk management, verification, validation, and product change processes.
• Support organizational growth by building and expanding the Design Assurance function.

Regulatory Affairs

• Oversee global regulatory strategies and submissions for medical device products.
• Ensure compliance with FDA regulations, international regulations, and applicable standards.
• Provide regulatory guidance for product development, labeling, claims, and market expansion initiatives.
• Maintain awareness of evolving regulatory requirements and assess impact on the organization.

Leadership & Team Development

• Lead a team of six direct reports across Design Assurance, Quality Systems, and Regulatory Affairs.
• Develop and mentor team members while fostering a culture of accountability, collaboration, and continuous improvement.
• Establish priorities, allocate resources, and drive execution against departmental objectives.
• Serve as a trusted advisor and business partner to executive leadership and cross-functional stakeholders.

Qualifications
Required Qualifications:

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related field.
• 10+ years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
• Demonstrated leadership experience managing quality and regulatory teams.
• Strong knowledge of FDA Quality System Regulations (21 CFR Part 820), Design Controls and Design Assurance, ISO 13485, Risk Management (ISO 14971), and global medical device regulatory requirements.
• Experience supporting regulatory submissions, audits, and inspections.
• Proven ability to influence cross-functional teams and drive organizational change.

Preferred Qualifications:

• Advanced degree and/or professional certifications (ASQ, RAC, etc.).
• Experience with Class II and/or Class III medical devices.
• Experience leading teams through quality system improvements, product development initiatives, and regulatory challenges.

Benefits
Our client offers a comprehensive benefits package designed to support your overall well-being and long-term success, including health and wellness coverage, competitive compensation, and financial security through 401(k) matching, profit sharing, and flexible spending and health savings accounts. Employees also receive personal protection benefits such as life and disability insurance, along with a strong focus on work-life balance through paid time off (PTO), paid parental leave (PPL), and company-paid holidays. Additionally, they are committed to your growth by providing ongoing professional development opportunities. How to Apply
Take the first step on your new career path!To submit yourself for consideration for this role, simply click the apply button and complete our mobile-friendly online application. Once weve reviewed your application details, a recruiter will reach out to you with next steps! Equal Opportunity Statement
As an equal opportunity employer, Dahl Consulting welcomes candidates of all backgrounds and experiences to apply. If this position sounds like the right opportunity for you, we encourage you to take the next step and connect with us. We look forward to meeting you!

#BP.Indeed #ZR #LI-LK1 #LI-OnsiteCompany DescriptionOur promise is simple. DAHL has proven year after year that we are flexible, consistent and easy to work with, which is why our clients and consultants have stayed with us, and we've continued to grow throughout the years.

Our clients know they can depend on our efforts, as we hold their priorities in high regard. We genuinely care about each and every relationship and promise to work with the utmost of respect, integrity and high energy, as we continually strive to build long-term relationships.

Company Description

Our promise is simple. DAHL has proven year after year that we are flexible, consistent and easy to work with, which is why our clients and consultants have stayed with us, and we've continued to grow throughout the years.\r\n \r\nOur clients know they can depend on our efforts, as we hold their priorities in high regard. We genuinely care about each and every relationship and promise to work with the utmost of respect, integrity and high energy, as we continually strive to build long-term relationships.