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From Home Fda Inspector Jobs in Maple Grove, MN (NOW HIRING)

Home Sales Inspector

Eden Prairie, MN · On-site

$70K - $100K/yr

Conducting full-home inspections (from attic to crawl space) * Build trust by explaining your findings clearly and recommending the best treatment options. * Close sales by showcasing the value ...

Conducting full-home inspections (from attic to crawl space) * Build trust by explaining your findings clearly and recommending the best treatment options. * Close sales by showcasing the value ...

... it from a Ryder Supply Chain Employee: Ryder Warehouse Associates work in clean, organized, and ... Experience with GMPs, FDA, USDA, etc. * Excellent written and verbal communication skills Important ...

... it from a Ryder Supply Chain Employee: Ryder Warehouse Associates work in clean, organized, and ... Experience with GMPs, FDA, USDA, etc. * Excellent written and verbal communication skills Important ...

100% Inspector

Minneapolis, MN · On-site

$20.63 - $30.25/hr

Food and Drug Administration (FDA) regulations, company policies and operating procedures, and ... Evaluates and selects solution from established options. * Provides support for operation floor ...

QA Inspector

Saint Paul, MN · On-site

$44K - $61K/yr

At Baxter, we believe every person-regardless of who they are or where they are from-deserves a ... Knowledge of GMP documentation and FDA required. * Demonstrated attention to details and accuracy ...

QA Inspector

Saint Paul, MN · On-site

$44K - $61K/yr

At Baxter, we believe every person-regardless of who they are or where they are from-deserves a ... Knowledge of GMP documentation and FDA required. * Demonstrated attention to details and accuracy ...

Vehicle Inspector

Shakopee, MN · On-site

$72K - $125K/yr

... homes. This makes for a very efficient day and productive day for earnings. Our inspectors' average wages range from $72,000 -$125,000 once training and assessments are completed which is the ...

... homes. This makes for a very efficient day and productive day for earnings. Our inspectors' average wages range from $72,000 -$125,000 once training and assessments are completed which is the ...

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Showing results 1-20

From Home Fda Inspector information

How do you become a from home FDA inspector?

To become a remote FDA inspector, candidates typically need a background in science, healthcare, or regulatory fields, along with relevant experience in inspections or compliance. Certification in areas such as food safety or pharmaceuticals can be beneficial, and strong analytical and communication skills are essential for conducting remote assessments and reporting findings.
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Infographic showing various From Home Fda Inspector job openings in Maple Grove, MN as of August 2026, with employment types broken down into 2% As Needed, 76% Full Time, 19% Part Time, and 3% Contract. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution.

Vice President, Quality Assurance & Regulatory Affairs

Mobia Medical, Inc.

Fridley, MN • On-site

$154K - $204K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

This job post has expired today. Applications are no longer accepted.


Job description

About Mobia Medical
Mobia Medical is a commercial-stage medtech company delivering breakthrough stroke recovery solutions. The company's Vivistim® Paired VNS™ Therapy is the first and only FDA-approved implantable solution designed to improve function in chronic ischemic stroke survivors with moderate to severe upper limb impairments. Vivistim® Paired VNS™ Therapy combines targeted vagus nerve stimulation with functional movement to promote neuroplasticity and improve the brain's ability to relearn motor skills. Mobia Medical is mobilizing patients, providers, and care partners to establish a better way forward in stroke care.
About the role
The Vice President of Quality Assurance & Regulatory Affairs is a key leadership role responsible for shaping and executing Mobia Medical's global quality and regulatory strategy. Reporting to the Chief Operating Officer, this leader will oversee the company's Quality Management System (QMS), global regulatory affairs, compliance initiatives with ISO 13485 and FDA 21 CFR Part 820 systems, and product approval strategies to support the continued growth of the Vivistim® platform.
This role partners closely with Clinical, R&D, Operations, Legal, and Executive Leadership to ensure quality and regulatory excellence is embedded throughout the product lifecycle-from development through commercialization and post-market surveillance. As the Person Responsible for Regulatory Compliance (PRRC-MDR), the VP will lead a global quality and regulatory organization while helping Mobia Medical for continued international expansion and innovation.
What you'll do
  • Provide strategic leadership for Mobia Medical's global Quality Assurance and Regulatory Affairs functions. Anticipate scope and scale changes with growth of the company, and plan and ensure suitable growth in the capability and capacity of the function.
  • Develop, maintain, and continuously improve the company's Quality Management System (QMS) to ensure compliance with FDA regulations, ISO 13485, cGMPs, EU MDR, and other applicable international standards. Understand and maintain all pertinent standards, regulations, and requirements for Mobia's business.
  • Ensure appropriate processes and systems for, and oversee, post-market surveillance activities, including Medical Device Reporting (MDR), Vigilance, Corrective and Preventive Actions (CAPA), field actions, and enterprise-wide quality and regulatory risk management.
  • Provide expertise and leadership to the design assurance function, to ensure appropriate design controls and traceability, risk management, verification and validation, a comprehensive design history file, and a compliant design transfer to production.
  • Develop and execute global regulatory strategies supporting IDE, 510(k), PMA, De Novo, and CE Mark submissions while serving as the organization's Person Responsible for Regulatory Compliance (PRRC-MDR).
  • Lead FDA inspections, global regulatory audits, and interactions with health authorities, including responses to inspections, audits, and technical documentation reviews.
  • Partner with Clinical, R&D, Operations, and Manufacturing teams to integrate quality, design assurance, and regulatory requirements throughout product development and sustaining engineering activities.
  • Collaborate with Legal to ensure ongoing compliance with applicable business and regulatory requirements.
  • Build, mentor, and lead a high-performing global Quality and Regulatory Affairs organization while establishing meaningful quality metrics and driving continuous improvement.
  • Serve as the executive authority on quality and regulatory compliance, providing strategic guidance to senior leadership and cross-functional stakeholders.

Qualifications
  • Bachelor's degree in a scientific, engineering, or other technical discipline.
  • 15+ years of progressive leadership experience in Quality Assurance and Regulatory Affairs within the medical device industry.
  • Deep expertise supporting Class II and/or Class III medical devices; experience with active implantable medical devices is strongly preferred.
  • Extensive knowledge of FDA regulations, ISO 13485, ISO 14971, EU MDR, and FDA 21 CFR Parts 801, 803, 806, and 820.
  • Demonstrated success leading FDA inspections, international regulatory submissions, and global quality management systems.
  • Proven experience building, mentoring, and leading high-performing quality and regulatory organizations.
  • Exceptional leadership, communication, and cross-functional collaboration skills with the ability to influence executive stakeholders.
  • Strong organizational, project management, and strategic planning capabilities.

Preferred Qualifications
  • Regulatory Affairs Certification (RAC), American Society for Quality (ASQ) certification, or similar professional credentials.
  • Experience serving as a Person Responsible for Regulatory Compliance (PRRC) under EU MDR.
  • Experience supporting commercial-stage, high-growth medical device organizations.
  • Demonstrated success developing global regulatory strategies for innovative implantable medical technologies.
  • Ability to thrive in a fast-paced, collaborative environment while driving continuous improvement and organizational excellence.

Equal Opportunity Employer
Mobia Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Benefits
Mobia Medical provides a comprehensive benefits program to employees. It includes medical, dental and vision plans along with an FSA. Employees may participate in the company 401(k) plan with company matching. The company offers an unlimited Paid Time Off (PTO) program and approximately 18 paid company holidays per year.
Apply now