ZipRecruiter

Log In

1

Regulatory Director Jobs (NOW HIRING)

Hawk Group

Alaska Regulatory Lead

Anchorage, AK · On-site

The Regulatory Director leads and coordinates all regulatory permitting and stakeholder engagement activities for the Client project in Alaska. This role works with the engineering team to meet all ...

The Gowan Co.

Global Regulatory Asset Lead

Yuma, AZ · On-site

Global Regulatory Director Key Responsibilities * Leadership and Team Management: The role will involve either a direct or indirect line in managing a team of Regulatory Managers assigned to ...

MBX Biosciences

Director, Regulatory

Boston, MA · Hybrid

$163K - $215K/yr

Position Summary The Director of Regulatory Affairs at MBX Biosciences will lead and execute global regulatory strategies that support the development and approval of MBX's clinical stage and early ...

Kinder Morgan

Director - Regulatory

Houston, TX · On-site

$143K - $189K/yr

Minimum 15 years direct work experience with regulatory matters, specifically certificate applications, in a natural gas industry environment is preferred. * Familiarity with agencies including the ...

Kinder Morgan

Director - Regulatory

Houston, TX · On-site

$143K - $189K/yr

Provide regulatory support to pipeline unit leaders in support of day-to-day operations. * Assist ... Minimum 10 years direct work experience with rates and tariffs in a natural gas industry ...

Hippocratic AI

Director, Regulatory

Menlo Park, CA · On-site

$176K - $233K/yr

Role Summary The Head of Regulatory is responsible for ensuring Hippocratic AI's life sciences platform meets the scientific, medical, and regulatory standards required to operate within life science ...

next page

Showing results 1-20

All JobsRegulatory JobsRegulatory Director Jobs

Regulatory Director information

See salary details

$91K

$176.2K

$248.5K

How much do regulatory director jobs pay per year?

As of Jul 18, 2026, the average yearly pay for regulatory director in the United States is $176,150.00, according to ZipRecruiter salary data. Most workers in this role earn between $150,000.00 and $198,000.00 per year, depending on experience, location, and employer.

What is the difference between Regulatory Director vs Regulatory Manager?

AspectRegulatory DirectorRegulatory Manager
ResponsibilitiesOversees regulatory strategies, compliance policies, and interacts with senior leadershipManages daily regulatory activities, ensures compliance, and implements policies
Required CredentialsTypically requires advanced degrees and extensive regulatory experienceRequires relevant certifications and several years of experience
Work EnvironmentStrategic, leadership-focused, often in corporate or global settingsOperational, team-oriented, often in specific departments or regions

The Regulatory Director focuses on strategic oversight and high-level compliance initiatives, while the Regulatory Manager handles daily regulatory operations and team management. Both roles require regulatory knowledge, but the director position involves broader leadership responsibilities.

How does a Regulatory Director typically collaborate with cross-functional teams to ensure compliance across the organization?

A Regulatory Director works closely with departments such as legal, quality assurance, research and development, and marketing to interpret and apply relevant regulations throughout the product lifecycle. They lead or participate in cross-functional meetings to provide regulatory guidance, address compliance risks, and help teams prepare for audits or submissions. This collaboration ensures that all departments are aligned with regulatory standards, minimizing risks and supporting smooth market access. Effective communication and negotiation skills are essential, as the Regulatory Director often acts as a bridge between technical teams and regulatory agencies.

What is a Regulatory Director?

A Regulatory Director is a senior professional responsible for overseeing and managing a company's compliance with regulations and laws relevant to its industry. They develop regulatory strategies, ensure products and processes meet legal standards, and often interact with government agencies. Their role is critical in industries like pharmaceuticals, finance, and healthcare, where regulations are complex and constantly evolving. Regulatory Directors also guide teams, provide regulatory advice during product development, and help minimize business risks associated with non-compliance.

What are the key skills and qualifications needed to thrive as a Regulatory Director, and why are they important?

To thrive as a Regulatory Director, you need deep expertise in regulatory affairs, compliance frameworks, and industry-specific regulations, typically supported by an advanced degree in law, science, or a related field. Familiarity with regulatory submission systems, document management tools, and certifications such as RAC (Regulatory Affairs Certification) are highly valued. Strong leadership, strategic thinking, and effective communication enable you to navigate complex regulations and lead cross-functional teams. These skills ensure timely product approvals, mitigate compliance risks, and support organizational growth in highly regulated industries.
More about Regulatory Director jobs
What cities are hiring for Regulatory Director jobs? Cities with the most Regulatory Director job openings:
What are the most commonly searched types of Regulatory jobs? The most popular types of Regulatory jobs are:
What states have the most Regulatory Director jobs? States with the most job openings for Regulatory Director jobs include:
Regulatory Director jobs near you
Quality & Regulatory Director

Quality & Regulatory Director

FloodGate Medical

Tampa, FL • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 3 days ago

Job description

Quality & Regulatory Director
Company: Nuwellis
Nuwellis is a medical device company dedicated to changing the lives of patients suffering from fluid overload with its Aquadex SmartFlow ultrafiltration therapy. They focus their efforts on understanding and meeting the critical needs associated with the treatment of fluid overload. As a global leader, they strive to make it easier for healthcare providers to quickly and gently restore fluid balance in all patients, in all settings, around the globe. Their patients are at the center of everything they do.
Why You Should Join Nuwellis
We're looking for a Quality & Regulatory Director to lead our Quality & Regulatory function and serve as our subject matter expert for FDA compliance and Quality Systems. Reporting to senior leadership, this position is responsible for maintaining an effective Quality Management System (QMS), ensuring regulatory compliance, supporting new product development activities, and driving continuous quality improvement across the organization.
This is a hands-on player-coach leadership role that combines strategic oversight with direct execution. The successful candidate will lead and develop a small Quality & Regulatory team while remaining actively involved in audits, regulatory submissions, CAPA activities, supplier quality management, and day-to-day quality system operations. As Nuwellis utilizes an outsourced manufacturing model, this role will work closely with our local contract manufacturing partners to ensure product quality, regulatory compliance, and operational excellence. This position requires prior experience in the medical device industry, extensive knowledge of FDA Quality Management System requirements (QMSR), ISO 13485, and related device regulations as well as significant experience overseeing contract manufacturers within a regulated environment. This is a full-time onsite position based in Eden Prairie, Minnesota.
What You'll Do
As a Quality & Regulatory Director, you will:
  • Lead the overall Quality Management System and ensure compliance with FDA Quality Management System Regulation (QMSR), ISO 13485, ISO 14971, and other applicable requirements.
  • Build strong partnerships with executive leadership to align quality and regulatory strategies with business objectives.
  • Direct and continuously improve core quality processes, including document control, record control, training, CAPA, change control, nonconformance management, customer feedback, and complaint handling.
  • Ensure corrective and preventive actions are comprehensive, effective, and completed in a timely manner.
  • Develop and implement quality objectives, metrics, and improvement initiatives aligned with company goals.
  • Identify quality trends, analyze data, and drive corrective actions and continuous improvement projects.
  • Maintain organizational inspection and audit readiness at all times.
  • Partner closely with the contract manufacturer by driving quality requirements to the contract manufacturer.
  • Lead internal audits, supplier audits, management reviews, and external regulatory or certification audits.
  • Serve as management representative for quality-related compliance activities as appropriate.
  • Act as the primary Quality leader for contract manufacturing oversight and supplier quality management.
  • Lead supplier qualification, approval, monitoring, and requalification activities.
  • Establish and maintain quality agreements with contract manufacturing and critical suppliers.
  • Conduct and oversee supplier audits, quality investigations, CAPAs, and performance reviews.
  • Partner with contract manufacturing organizations to resolve quality issues, implement improvements, and ensure ongoing compliance.
  • Ensure product acceptance activities and supplier controls are effectively maintained within the outsourced manufacturing model.
  • Lead regulatory strategy and submission activities for U.S. medical device compliance.
  • Prepare and maintain FDA submissions and regulatory documentation, including product changes, reports, and other required filings.
  • Assess regulatory impact of design, process, manufacturing, supplier, and labeling changes.
  • Support product development projects by providing regulatory guidance and quality oversight.
  • Serve as the primary interface with FDA and other applicable regulatory agencies.
  • Monitor evolving regulations, standards, and guidance, and communicate business impacts to leadership.
  • Support post-market regulatory compliance and reporting requirements.
  • Lead, coach, develop, and evaluate Quality & Regulatory team members.
  • Foster a culture of quality, accountability, compliance, and continuous improvement.
  • Partner cross-functionally with operations, engineering, clinical, commercial, and executive leadership teams to achieve company objectives.
  • Provide practical, business-oriented quality and regulatory guidance to support organizational growth and innovation.

What You'll Need
  • Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related technical discipline (Bachelor's degree required, but flexible on field).
  • 8-10+ years of Quality and/or Regulatory experience within the medical device industry.
  • Experience supporting Class II and/or Class III medical devices, preferred.
  • Significant experience with FDA Quality System requirements and ISO 13485/ISO 14971.
  • Demonstrated experience managing Quality Systems within an outsourced or contract manufacturing environment.
  • Experience qualifying, auditing, and managing contract manufacturers and critical suppliers.
  • Proven experience leading regulatory inspections, quality audits, and compliance activities.
  • Experience with CAPA, complaint handling, change control, supplier quality, and document control systems.
  • Strong ability to balance strategic leadership with hands-on execution.
  • Ability to work full-time onsite at HQ in Eden Prairie, Minnesota. Open to candidates residing within a 45-minute drive.
  • Must be authorized to work in the United States without sponsorship.

Perks of the Job
Compensation: $150-183K (flexible based upon experience)
Comprehensive Benefits Package: eligible for annual discretionary bonus, medical insurance including a High-Deductible Health Plan with an annual company HSA contribution of $2K for individual coverage or $4K for family coverage, dental/vision insurance, employer-paid life insurance plus STD & LTD coverage, ample PTO/floating holidays/company paid holidays, and 401k with a 3% company match.

Apply