Are you an experienced regulatory affairs leader with a passion for ensuring compliance and navigating complex regulatory landscapes? We are seeking a Director of Regulatory Affairs (Medical Device) in Austin, TX, to lead regulatory strategies, oversee compliance processes, and drive successful product approvals. This executive role requires a strategic thinker with deep expertise in FDA, ISO, MDR, and global regulatory requirements for medical devices. If you have a proven track record of managing regulatory affairs and facilitating successful product launches, this opportunity is for you.
As the Director of Regulatory Affairs (Medical Device) in Austin, TX, you will be responsible for overseeing regulatory submissions, maintaining compliance with evolving regulations, and collaborating with cross-functional teams to ensure seamless market access. Your leadership will be instrumental in shaping regulatory policies, liaising with government agencies, and supporting innovation while upholding the highest standards of regulatory compliance. If you thrive in a fast-paced, highly regulated industry and possess exceptional problem-solving skills, we encourage you to apply.
About This Role
The Director of Regulatory Affairs (Medical Device) in Austin, TX, plays a critical role in ensuring that all medical devices comply with regulatory standards at both national and international levels. This position requires a proactive leader who can develop and execute regulatory strategies, maintain compliance, and facilitate timely product approvals. You will be the key point of contact for regulatory agencies, ensuring that all company products meet FDA, EU MDR, Health Canada, and other global medical device regulations.
In this role, you will oversee the preparation and submission of regulatory documentation, lead audits and inspections, and implement quality control measures. Working closely with R&D, clinical affairs, quality assurance, and commercial teams, you will ensure that regulatory compliance is integrated into every stage of product development and market entry. The Director of Regulatory Affairs (Medical Device) in Austin, TX, will be instrumental in driving innovation while ensuring compliance with the latest industry standards. This is a unique opportunity to join a growing medical device company and shape the future of regulatory excellence in the industry.
Key Responsibilities – Director of Regulatory Affairs (Medical Device) in Austin, TX
1. Develop and Execute Regulatory Strategies
- Create and implement comprehensive regulatory strategies for FDA, EU MDR, and international submissions.
- Ensure alignment of regulatory strategies with business objectives and market expansion plans.
- Monitor regulatory trends and anticipate changes that may impact product approvals.
2. Oversee Regulatory Submissions and Approvals
- Prepare and submit 510(k), PMA, CE Mark, Health Canada, and other regulatory filings.
- Manage correspondence and interactions with regulatory agencies to facilitate approvals.
- Ensure timely responses to regulatory inquiries and deficiency letters.
3. Ensure Compliance with Global Regulatory Standards
- Maintain up-to-date knowledge of FDA, ISO 13485, MDR, MDSAP, and other regulations.
- Implement and oversee compliance programs across all regulatory activities.
- Conduct internal audits and ensure corrective actions are implemented effectively.
4. Manage Product Labeling and Marketing Compliance
- Review and approve product labeling, instructions for use (IFUs), and marketing materials.
- Ensure all promotional content meets regulatory guidelines and industry best practices.
- Provide regulatory guidance on advertising, claims, and branding strategies.
5. Lead Regulatory Risk Assessment and Mitigation
- Identify potential regulatory risks in product development and commercialization.
- Develop risk management strategies to address compliance concerns.
- Work with quality and legal teams to proactively resolve regulatory challenges.
6. Collaborate with Cross-Functional Teams
- Partner with R&D, quality assurance, clinical affairs, and marketing to ensure regulatory requirements are met.
- Provide regulatory input on product design, clinical trial planning, and manufacturing processes.
- Offer guidance on post-market surveillance and adverse event reporting.
7. Manage Regulatory Inspections and Audits
- Lead FDA, ISO, and notified body audits, ensuring successful compliance outcomes.
- Develop and implement corrective action plans to address audit findings.
- Train internal teams on regulatory requirements and audit readiness.
8. Drive Continuous Improvement in Regulatory Affairs
- Implement best practices for regulatory affairs processes and documentation.
- Foster a culture of regulatory excellence and compliance within the organization.
- Stay ahead of industry trends, participating in regulatory forums and advocacy groups.
What The Client is Looking For in You
To succeed as the Director of Regulatory Affairs (Medical Device) in Austin, TX, you must be a highly strategic and detail-oriented regulatory leader with a deep understanding of the medical device industry. The ideal candidate will have:
- Extensive Regulatory Affairs Experience – At least 10+ years of experience in regulatory affairs within the medical device industry, with a strong background in FDA submissions, EU MDR compliance, and global regulatory approvals.
- Proven Track Record in Regulatory Submissions – Demonstrated success in leading 510(k), PMA, CE Mark, Health Canada, and international regulatory submissions, ensuring successful product approvals.
- Strong Leadership and Team Management Skills – Experience leading regulatory teams, managing cross-functional collaborations, and working with senior leadership to align regulatory goals with business objectives.
- Expertise in Global Medical Device Regulations – In-depth knowledge of FDA, ISO 13485, MDR, MDSAP, and other international regulatory frameworks.
- Analytical and Strategic Thinking – Ability to assess regulatory risks, develop mitigation strategies, and ensure proactive compliance.
- Excellent Communication and Negotiation Skills – Strong ability to interact with regulatory agencies, internal teams, and external stakeholders to facilitate approvals and compliance.
- Attention to Detail and Process Improvement – A meticulous approach to regulatory documentation, audits, and quality control.
- Ability to Manage Regulatory Inspections – Experience handling FDA and ISO audits, responding to regulatory inquiries, and leading corrective actions when necessary.
This role requires a forward-thinking regulatory leader who can navigate complex compliance landscapes while supporting product innovation and market growth. If you thrive in a highly regulated environment and enjoy working at the intersection of compliance and strategy, this position is for you.
Why This Opportunity Stands Out
As the Director of Regulatory Affairs (Medical Device) in Austin, TX, you will have the opportunity to:
- Lead Regulatory Strategy for an Innovative Medical Device Company – Play a pivotal role in shaping the company’s regulatory direction and ensuring successful global product approvals.
- Drive Market Expansion and Compliance Excellence – Help launch cutting-edge medical devices while ensuring compliance with evolving regulatory requirements.
- Competitive Compensation & Executive Benefits – Receive a lucrative salary, performance-based incentives, and a comprehensive benefits package.
- Work in a High-Growth Industry – Join a company that is rapidly expanding in the medical device sector, offering stability and long-term career growth.
- Collaborate with a World-Class Leadership Team – Work alongside top executives, scientists, engineers, and quality professionals who are dedicated to delivering groundbreaking medical technologies.
- Influence Regulatory Policy and Compliance Best Practices – Your expertise will directly impact the company’s ability to bring life-changing medical devices to market.
- Be at the Forefront of Medical Innovation – Contribute to a company that is making a difference in patient care and healthcare advancements.
This is a rare opportunity to take on a leadership role in regulatory affairs and make a significant impact in the medical device industry. If you are ready to advance your career and help shape the future of regulatory compliance, we encourage you to apply.
FAQs About the Role
Q: What industries should I have experience in?
A: You should have a strong background in the medical device industry, with experience in regulatory submissions, compliance, and quality assurance.
Q: Is relocation required for this position?
A: This role is based in Austin, TX. Candidates should be open to relocation or already reside in the area.
Q: What is the reporting structure for this role?
A: The Director of Regulatory Affairs (Medical Device) in Austin, TX, will report directly to the Vice President of Regulatory and Quality Affairs and work closely with senior leadership.
Q: What are the main regulatory requirements I will be responsible for?
A: You will oversee compliance with FDA, ISO 13485, EU MDR, MDSAP, Health Canada, and other global regulatory standards.
Q: What are the key responsibilities of this position?
A: You will develop regulatory strategies, lead submissions, manage audits, ensure compliance, and oversee post-market surveillance.
Q: What is the expected travel requirement?
A: This role may require occasional domestic and international travel for regulatory meetings, audits, and industry conferences.
Q: What qualifications and skills are required?
A: A bachelor’s or master’s degree in regulatory affairs, biomedical engineering, life sciences, or a related field is required. You should also have 10+ years of regulatory experience in the medical device sector.
Q: What is the hiring timeline for this position?
A: The company is actively seeking the right candidate and aims to complete the hiring process within the next 60–90 days. Onboarding will include training, strategy meetings, and compliance briefings.
What Remuneration Can You Expect from This Job?
As the Director of Regulatory Affairs (Medical Device) in Austin, TX, you can expect a highly competitive compensation package that reflects the leadership and expertise required for this critical role. The base salary typically ranges from $180,000 – $220,000 per year, depending on experience, regulatory expertise, and past success in securing global medical device approvals.
In addition to the base salary, this role offers performance-based bonuses tied to key regulatory milestones, successful product approvals, and compliance excellence. Equity options or stock grants may also be available for the right candidate, 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 professional development opportunities such as industry conferences and regulatory training programs. Additional perks may include relocation assistance, executive-level benefits, and travel allowances for regulatory meetings and conferences.
This role offers not only a highly competitive financial package but also the opportunity to shape regulatory strategies, lead compliance efforts, and drive market success in the medical device industry.
How to Apply for This Director of Regulatory Affairs (Medical Device) Position in Austin, TX
If you are a seasoned regulatory professional with a proven track record in medical device approvals and compliance, we invite you to apply for the Director of Regulatory Affairs (Medical Device) in Austin, TX. This is an exceptional opportunity to lead global regulatory strategies, ensure compliance excellence, and contribute to a growing medical technology company.
To apply, please submit your resume and a cover letter detailing your experience in regulatory submissions, compliance leadership, and global market approvals.
This role offers a rewarding career path in a high-growth medical device company, where you will have the opportunity to lead a world-class regulatory team and shape the future of compliance in the industry. Apply today to take the next step in your regulatory affairs leadership career in Austin, TX!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
Tags:
Director of Regulatory Affairs | Medical Device Regulatory Compliance | FDA Regulatory Expert | Regulatory Affairs Leadership | Medical Device Approval
