Senior Manager of Quality and Regulatory

Job Description

Title : Senior Manager of Quality and Regulatory

Location : Plymouth, MN

Job Type : Permanent

Compensation : $160,000 - $180,000 + Bonus

Industry: Medical Device and Healthcare Technology
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About the Role
Our firm is partnering with a Twin Cities-based medical device manufacturer to identify a Senior Manager of Quality and Regulatory to join their Quality and Operations Leadership Team. Our client is an established innovator in noninvasive patient monitoring technology, developing FDA-cleared and internationally certified medical devices used in hospitals, clinics, and home care settings worldwide. This is a strategic leadership opportunity to shape design assurance and global regulatory compliance across the full product life cycle for a company with a strong reputation for engineering excellence and patient-centered innovation. Job Description
The Senior Manager of Quality and Regulatory will provide strategic and operational leadership for Design Assurance and Regulatory compliance in support of enterprise business objectives. This role ensures compliance with global regulations, quality management system (QMS) standards, and design control processes while supporting new product development, product changes, and post-market activities.
Key responsibilities include:

• Providing strategic Regulatory and Quality guidance to executive leadership and internal stakeholders.
• Collaborating with executive management on departmental organizational planning, operating model, strategy deployment, and governance procedures.
• Interpreting evolving regulatory requirements and communicating business impacts across the organization.
• Maintaining product registrations and regulatory compliance across global markets, including managing the international registration process, organization, maintenance of current registrations, and future strategic planning of global submissions.
• Ensuring company products and operations comply with applicable regulatory standards, including FDA QSR, ISO 13485, and EU MDR, with emphasis on regulatory and design quality requirements.
• Driving regulatory, design quality, and product development process improvements using continuous improvement approaches.
• Participating in project teams to provide regulatory and design assurance leadership and input.
• Facilitating achievement of business objectives through a risk-based approach while ensuring quality and regulatory compliance within the flexibility of the regulations.
• Enabling compliant, efficient, and risk-based execution of clinical affairs processes, as well as product verification and validation activities.
• Developing and growing a high-performing team to support regulatory and design assurance organizational needs, and facilitating organizational cohesiveness with the company's operating model, business strategy, and culture of regulatory/design assurance compliance.
• Leading efforts in support of QMS and compliance remediation activities.
• Driving new product development quality strategy, including identification of applicable standards, design verification testing, and human factors engineering.
• Developing and leading strategic relationships with third-party contract research organizations and testing service providers.
• Facilitating and supporting audits by applicable regulatory agencies, including FDA, EU notified body, and customers.

Qualifications

Required Qualifications:

• 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 510(k), PMA, medical devices, Software as a Medical Device (SaMD), non-medical device software, combination products, or digital health technologies.
• Expertise with global regulatory submissions outside of the United States and Europe.
• Working knowledge of applicable regulations including FDA QSR, ISO 13485, EU MDR/MDD, and Design Controls.
• Experience supporting new product development from concept through commercialization.
• Strong written and verbal communication skills, particularly when interacting 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 the development, deployment, and execution of quality and compliance strategy.
• Ability to sit and/or stand for 8 hours per day.

Preferred Qualifications:

• Advanced degree and/or professional certification in regulatory, quality, or compliance.
• Regulatory Affairs Certification (RAC).
• Experience with electrical-mechanical devices.

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 we've 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!


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Dahl Consulting is proud to offer a comprehensive benefits package to eligible contract employees that will allow you to choose the best coverage to meet your family's needs. For details, please review our Benefits Summary:


Dahl Consulting is an Equal Opportunity Employer and does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other applicable legally protected characteristics.


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