Are you an experienced clinical affairs professional with a passion for driving clinical strategies in the medical device industry? We are seeking a Director of Clinical Affairs (Medical Device) in Austin, TX, to lead clinical research, regulatory compliance, and evidence generation to support product development and commercialization. This executive role requires a visionary leader with a deep understanding of clinical trial management, regulatory submissions, and post-market surveillance within the medical device sector.
As the Director of Clinical Affairs (Medical Device) in Austin, TX, you will be responsible for designing and overseeing clinical studies, ensuring compliance with FDA and international regulatory requirements, and collaborating with key opinion leaders to generate clinical data that supports product innovation. If you are a strategic thinker with extensive experience in clinical research and a proven ability to lead cross-functional teams, this is a unique opportunity to make a significant impact in the healthcare industry.
About This Role
The Director of Clinical Affairs (Medical Device) in Austin, TX, plays a crucial role in shaping the clinical strategy and ensuring regulatory compliance for the company’s medical device portfolio. This position requires a leader with strong expertise in clinical trial design, regulatory affairs, and post-market surveillance. You will work closely with R&D, regulatory, and marketing teams to develop clinical evidence that supports product approvals and market adoption.
This role demands a detail-oriented professional who can oversee all aspects of clinical research, from protocol development and study execution to data analysis and regulatory submissions. The Director of Clinical Affairs (Medical Device) in Austin, TX, will also be responsible for engaging with investigators, regulatory bodies, and key stakeholders to drive successful clinical outcomes. This is an exceptional opportunity to contribute to groundbreaking medical innovations while ensuring the highest standards of clinical research and patient safety.
Key Responsibilities – Director of Clinical Affairs (Medical Device) in Austin, TX
1. Develop and Oversee Clinical Strategy
- Design and implement clinical strategies to support regulatory approvals and market adoption.
- Align clinical programs with business objectives and product development goals.
- Ensure compliance with global regulatory requirements for clinical trials.
2. Lead Clinical Trial Management
- Oversee the planning, execution, and monitoring of clinical trials from start to completion.
- Ensure adherence to Good Clinical Practice (GCP) guidelines and ethical standards.
- Manage relationships with contract research organizations (CROs) and clinical sites.
3. Regulatory Submissions and Compliance
- Prepare and submit clinical trial applications to regulatory agencies such as the FDA and EMA.
- Collaborate with regulatory affairs teams to support product approvals and labeling claims.
- Ensure all clinical activities comply with industry regulations and internal policies.
4. Data Collection, Analysis, and Reporting
- Oversee the collection and interpretation of clinical data to support product claims.
- Develop clinical study reports and publications for regulatory and marketing use.
- Present clinical findings to internal stakeholders and external regulatory bodies.
5. Post-Market Surveillance and Risk Management
- Monitor product performance and safety through post-market clinical follow-ups.
- Conduct risk assessments and implement corrective actions as needed.
- Collaborate with quality and regulatory teams to address any clinical concerns.
6. Key Opinion Leader (KOL) and Investigator Engagement
- Establish relationships with key opinion leaders, physicians, and clinical investigators.
- Organize advisory board meetings and investigator training programs.
- Leverage KOL insights to refine clinical study designs and product positioning.
7. Budget and Resource Management
- Manage clinical trial budgets, ensuring cost-effective study execution.
- Allocate resources effectively to meet clinical program objectives.
- Negotiate contracts with CROs, clinical sites, and vendors.
8. Cross-Functional Collaboration and Leadership
- Work closely with R&D, marketing, and regulatory teams to integrate clinical insights into product development.
- Provide leadership and mentorship to clinical affairs teams.
- Represent the company at scientific conferences and regulatory meetings.
What The Client is Looking For in You
To succeed as the Director of Clinical Affairs (Medical Device) in Austin, TX, you should bring a combination of clinical expertise, leadership capabilities, and a strategic mindset. The ideal candidate will possess:
- Extensive Experience in Clinical Affairs – A strong background in clinical trial design, execution, and regulatory submissions within the medical device industry.
- In-Depth Knowledge of Regulatory Requirements – Expertise in FDA, EMA, and global regulatory processes related to clinical research and product approvals.
- Proven Leadership in Clinical Research – A track record of successfully managing clinical teams, CROs, and multi-site studies.
- Strong Data Analysis and Interpretation Skills – Ability to translate clinical trial data into meaningful insights that support regulatory and business decisions.
- Exceptional Communication and Stakeholder Management – Experience collaborating with key opinion leaders, investigators, and regulatory agencies.
- Financial and Budgeting Acumen – Ability to manage clinical study budgets, allocate resources efficiently, and optimize costs.
- Passion for Innovation and Patient-Centric Solutions – A commitment to improving patient outcomes through clinical research and medical advancements.
Why This Opportunity Stands Out
This role presents a unique opportunity to be at the forefront of clinical strategy and medical innovation. As the Director of Clinical Affairs (Medical Device) in Austin, TX, you will:
- Lead Pivotal Clinical Research Efforts – Drive groundbreaking clinical studies that shape the future of medical device innovations.
- Be Part of an Expanding Medical Device Company – Join a company experiencing rapid growth and committed to bringing life-changing medical technologies to market.
- Influence Regulatory Approvals and Market Success – Play a key role in securing regulatory approvals and positioning products for commercial success.
- Competitive Compensation & Benefits – Enjoy an attractive salary package, performance-based incentives, and executive-level benefits.
- Collaborate with Top Industry Experts – Work alongside R&D teams, regulatory leaders, and renowned clinical investigators.
- Make a Meaningful Impact in Healthcare – Contribute to the development of safe and effective medical solutions that enhance patient care worldwide.
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 extensive experience in clinical affairs, regulatory submissions, and clinical trial management.
Q: Is relocation required for this position?
A: The role is based in Austin, TX. Candidates must be open to relocation or already reside in the area.
Q: What is the reporting structure for this role?
A: The Director of Clinical Affairs (Medical Device) in Austin, TX will report directly to the Vice President of Clinical & Regulatory Affairs and collaborate closely with R&D and commercial teams.
Q: What kind of leadership style is expected?
A: We are looking for a strategic, results-oriented leader who fosters collaboration, drives innovation, and maintains a high level of regulatory and ethical standards.
Q: What is the expected travel requirement?
A: This role may require domestic and international travel for clinical trial site visits, regulatory meetings, and industry conferences.
Q: What qualifications and skills are required?
A: A master’s or doctoral degree in a relevant scientific or medical field is preferred. Candidates should have at least 10+ years of experience in clinical affairs, along with expertise in FDA and international regulatory requirements.
Q: How does this role contribute to the company’s overall success?
A: The Director of Clinical Affairs (Medical Device) in Austin, TX ensures that clinical studies generate the necessary evidence for regulatory approvals, product safety, and market adoption, ultimately driving business growth.
Q: What is the timeline for hiring and onboarding?
A: The company aims to complete the hiring process within the next 60–90 days. Onboarding will include strategy sessions with leadership, in-depth training on clinical programs, and alignment on clinical study objectives.
What Remuneration Can You Expect from This Job?
As the Director of Clinical Affairs (Medical Device) in Austin, TX, you can expect a highly competitive compensation package that reflects your expertise in clinical research, regulatory affairs, and leadership. The base salary for this role typically falls in the range of $180,000 – $250,000 per year, depending on your experience, industry knowledge, and past successes in managing clinical trials and regulatory approvals.
In addition to a strong base salary, this position offers performance-based bonuses tied to clinical trial milestones, regulatory approvals, and successful product launches. Equity options or stock grants may also be available, 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) plan with company matching, paid time off, professional development programs, and executive-level perks. Additional benefits may include a relocation package, travel allowances, and opportunities to attend industry conferences and regulatory meetings.
This role not only offers a lucrative financial package but also provides the chance to lead high-impact clinical studies, work with top industry experts, and contribute to the success of innovative medical technologies that improve patient outcomes worldwide.
How to Apply for This Director of Clinical Affairs (Medical Device) Position in Austin, TX
If you are a seasoned clinical affairs professional with a strong track record in leading clinical trials and securing regulatory approvals, we invite you to apply for the Director of Clinical Affairs (Medical Device) in Austin, TX. This is an excellent opportunity to drive clinical research strategies, collaborate with top healthcare professionals, and shape the future of medical innovations.
To apply, please submit your resume and a cover letter detailing your experience in clinical trial management, regulatory compliance, and medical device product development.
This role offers a rewarding opportunity to work at the forefront of medical technology, ensuring that groundbreaking medical devices receive the clinical validation they need for market success. Apply today to take the next step in your career as a Director of Clinical Affairs (Medical Device) in Austin, TX!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
Tags:
Director of Clinical Affairs | Medical Device Clinical Trials | Regulatory Compliance | Clinical Research Leadership | Medical Device Industry | Clinical Affairs Executive
