Are you an expert in regulatory affairs within the medical device industry? We are seeking a Director of Regulatory Operations (Med Device) in Phoenix, AZ to lead and oversee regulatory strategies, submissions, and compliance efforts. This leadership role requires a seasoned professional with deep knowledge of FDA regulations, ISO standards, and international regulatory requirements to ensure successful product approvals and market access.

As the Director of Regulatory Operations (Med Device) in Phoenix, AZ, you will play a critical role in shaping regulatory policies, managing submissions, and collaborating with cross-functional teams to maintain compliance. If you have a track record of success in regulatory leadership and a passion for bringing innovative medical devices to market, we want to hear from you.

About This Role

The Director of Regulatory Operations (Med Device) in Phoenix, AZ is responsible for driving the regulatory strategy and ensuring compliance with global medical device regulations. This position involves overseeing regulatory submissions, managing audits, and staying ahead of evolving industry standards. You will work closely with R&D, quality assurance, and marketing teams to navigate complex regulatory landscapes and facilitate product approvals.

This role requires an experienced leader with a deep understanding of regulatory requirements for Class I, II, and III medical devices, the ability to liaise with regulatory agencies, and expertise in managing documentation for successful submissions. By leveraging your regulatory expertise, you will help the company maintain compliance while accelerating market entry for cutting-edge medical devices.

Key Responsibilities – Director of Regulatory Operations (Med Device) in Phoenix, AZ

Develop and Implement Regulatory Strategies

Lead the development and execution of global regulatory strategies for new and existing medical devices.
Assess regulatory risks and provide guidance on regulatory pathways, including FDA 510(k), PMA, De Novo, and CE Mark submissions.
Ensure alignment between business objectives and regulatory requirements to support product approvals and market expansion.

Manage Regulatory Submissions and Approvals

Oversee the preparation, submission, and maintenance of regulatory filings, including 510(k), PMA, and international registrations.
Collaborate with cross-functional teams to gather and compile necessary documentation for regulatory submissions.
Monitor submission timelines and communicate with regulatory authorities to facilitate smooth approvals.

Ensure Compliance with FDA, ISO, and Global Regulations

Maintain compliance with FDA, ISO 13485, MDR, IVDR, and other global regulatory requirements.
Lead internal audits and ensure proper documentation and record-keeping for regulatory compliance.
Provide regulatory training and updates to internal teams to ensure ongoing adherence to industry standards.

Oversee Product Labeling, Claims, and Marketing Compliance

Review and approve product labeling, advertising, and promotional materials for regulatory compliance.
Ensure that marketing claims are substantiated and aligned with regulatory guidelines.
Work closely with legal and marketing teams to mitigate regulatory risks associated with product communication.

Manage Regulatory Interactions and Communications

Serve as the primary liaison between the company and regulatory agencies, including the FDA, EMA, and other global bodies.
Represent the company in regulatory meetings, panel discussions, and industry forums.
Respond to regulatory inquiries and address deficiencies to ensure continued product approvals.

Lead and Mentor Regulatory Affairs Team

Build and manage a high-performing regulatory affairs team, fostering a culture of compliance and excellence.
Provide mentorship, guidance, and professional development opportunities to regulatory staff.
Ensure team alignment with corporate goals and regulatory best practices.

Monitor Regulatory Trends and Industry Changes

Stay updated on evolving regulatory requirements, industry trends, and policy changes affecting medical devices.
Analyze regulatory developments and provide recommendations to senior leadership on necessary compliance adjustments.
Implement proactive strategies to address regulatory changes and maintain market competitiveness.

Support Quality Assurance and Risk Management Initiatives

Collaborate with the quality assurance team to align regulatory compliance with quality management systems (QMS).
Participate in risk assessments, corrective actions, and product safety evaluations.
Ensure a seamless integration of regulatory and quality processes to uphold product integrity and compliance.

What The Client is Looking For in You

To succeed as the Director of Regulatory Operations (Med Device) in Phoenix, AZ, you must possess a strong combination of regulatory expertise, leadership skills, and a proactive approach to compliance. The ideal candidate will have:

Extensive Regulatory Affairs Experience – At least 10+ years of experience in regulatory affairs within the medical device industry, including hands-on experience with FDA 510(k), PMA, CE Mark, and international product approvals.
Strong Leadership & Team Management – Proven ability to lead, mentor, and develop a high-performing regulatory team, ensuring alignment with corporate goals and compliance requirements.
Expert Knowledge of Global Regulations – Deep understanding of FDA, ISO 13485, MDR, IVDR, and other global regulatory frameworks, ensuring all products meet necessary compliance standards.
Strategic Thinking & Problem-Solving Abilities – Ability to assess regulatory risks, navigate complex approval processes, and develop innovative solutions to accelerate product approvals.
Excellent Communication & Regulatory Liaison Skills – Experience interacting with regulatory agencies such as the FDA, EMA, and international bodies, managing regulatory inquiries, and negotiating successful product clearances.
Meticulous Attention to Detail – Strong technical writing and documentation skills to ensure accurate and compliant regulatory submissions.
Collaboration Across Departments – Ability to work cross-functionally with R&D, quality assurance, legal, and marketing teams to integrate regulatory strategies with business objectives.
Passion for Compliance & Innovation – A commitment to ensuring patient safety, product efficacy, and staying ahead of regulatory changes in a rapidly evolving industry.

Why This Opportunity Stands Out

This role offers an exciting opportunity for regulatory leaders looking to make a significant impact in the medical device industry. As the Director of Regulatory Operations (Med Device) in Phoenix, AZ, you will:

Lead Regulatory Strategy at a Growing Med Device Company – Be at the forefront of shaping and executing global regulatory strategies to bring cutting-edge medical devices to market.
Work with Innovative Medical Technologies – Gain hands-on experience with breakthrough medical device solutions, improving patient outcomes and healthcare innovation.
Engage with High-Profile Regulatory Agencies – Lead direct interactions with FDA, EMA, and international regulatory bodies, influencing approval timelines and compliance initiatives.
Competitive Compensation & Executive Benefits – Receive a highly competitive salary, performance-based incentives, and a comprehensive benefits package tailored for executive-level professionals.
Be a Key Player in Global Market Expansion – Help drive regulatory strategies for international market entry, shaping the company’s global footprint.
Dynamic & Collaborative Work Environment – Join a culture of innovation, teamwork, and excellence, where your expertise is valued, and your leadership makes a tangible difference.

FAQs About the Role

Q: What industries should I have experience in?
A: You should have a strong background in medical device regulatory affairs, with direct experience in FDA, ISO 13485, MDR, IVDR, and other regulatory frameworks.

Q: Does this role require relocation?
A: The position is based in Phoenix, AZ. Candidates should either be located in Phoenix or open to relocation for this executive-level role.

Q: What is the reporting structure for this role?
A: The Director of Regulatory Operations (Med Device) in Phoenix, AZ will report directly to the Vice President of Regulatory Affairs and collaborate closely with R&D, quality, and marketing teams.

Q: What level of regulatory submissions experience is required?
A: Candidates must have hands-on experience leading 510(k), PMA, De Novo, and CE Mark submissions for Class I, II, and III medical devices.

Q: How much travel is required for this position?
A: Some domestic and international travel may be required, particularly for regulatory meetings, audits, and industry conferences.

Q: What are the key leadership expectations for this role?
A: The company is looking for a strategic, detail-oriented leader who can develop regulatory strategies, manage a team, and collaborate with cross-functional teams.

Q: What is the hiring timeline for this position?
A: The company aims to fill this position within the next 60-90 days. The onboarding process will include regulatory strategy meetings and deep dives into current compliance initiatives.

Q: How does this role contribute to the company’s success?
A: The Director of Regulatory Operations (Med Device) in Phoenix, AZ will play a critical role in securing regulatory approvals, ensuring compliance, and driving the successful commercialization of medical devices worldwide.

What Remuneration Can You Expect from This Job?

As the Director of Regulatory Operations (Med Device) in Phoenix, AZ, you can expect a highly competitive compensation package that reflects your expertise in regulatory affairs and leadership within the medical device industry. The base salary for this position ranges between $180,000 – $220,000 per year, depending on experience, industry knowledge, and the ability to drive regulatory success.

Beyond the base salary, this role includes performance-based bonuses and incentives, tied to key regulatory achievements such as successful 510(k), PMA, CE Mark, and MDR approvals, as well as strategic compliance initiatives. Additionally, equity options or stock grants may be offered, allowing you to share in the company’s long-term success.

The benefits package includes comprehensive healthcare coverage (medical, dental, and vision), a 401(k) retirement plan with company matching, generous paid time off, and executive-level perks. Relocation assistance may be available for qualified candidates. You will also receive travel allowances for regulatory meetings and industry conferences, along with professional development opportunities to stay ahead in the evolving regulatory landscape.

This role not only offers financial rewards but also the opportunity to shape regulatory strategies for innovative medical technologies, ensuring compliance while bringing life-changing devices to global markets.

How to Apply for This Director of Regulatory Operations (Med Device) Position in Phoenix, AZ

If you are a proven regulatory leader with extensive experience in medical device compliance, we invite you to apply for the Director of Regulatory Operations (Med Device) in Phoenix, AZ. This is a unique opportunity to lead regulatory strategies, drive compliance success, and work with cutting-edge medical device technologies.

To apply, please submit your resume and a cover letter detailing your regulatory expertise, leadership experience, and success in securing product approvals across global markets.

This role provides an exciting career path for regulatory professionals who want to make an impact on product innovation, patient safety, and international market expansion. Apply today to take the next step in your executive career as a Director of Regulatory Operations (Med Device) in Phoenix, AZ!

For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.

Tags:

Job Category: Director of Regulatory Operations

Job Type: Full Time

Job Location: Phoenix

Director of Regulatory Operations (Med Device) in Phoenix, AZ