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# Senior Clinical Affairs Manager (Med Device) in Raleigh, NC


Are you an experienced clinical affairs professional with a strong background in the medical device industry? We are seeking a Senior Clinical Affairs Manager (Med Device) in Raleigh, NC, to lead clinical trials, ensure regulatory compliance, and drive the successful development of medical device products. This is an exciting opportunity to join a dynamic team and play a key role in advancing cutting-edge medical technologies that improve patient outcomes.
About The Role
As the Senior Clinical Affairs Manager (Med Device) in Raleigh, NC, you will take the lead in managing the clinical development process for medical devices. Your role will focus on overseeing clinical trial design, implementation, and management, ensuring all regulatory and compliance requirements are met. You will collaborate closely with cross-functional teams including R&D, regulatory affairs, and quality assurance, ensuring the successful development of products that meet both clinical and regulatory standards. If you have a passion for clinical research and a track record in the medical device field, we encourage you to apply for this exciting leadership opportunity.
Key Responsibilities – Senior Clinical Affairs Manager (Med Device) in Raleigh, NC
1. Manage Clinical Trials and Research Initiatives

Oversee the design and execution of clinical trials for medical devices.
Coordinate with research teams to ensure proper study setup, including site selection and patient recruitment.
Monitor trial progress and address any issues related to trial timelines and patient safety.

2. Ensure Regulatory Compliance and Approvals

Ensure that all clinical trials comply with regulatory requirements, including FDA and ISO guidelines.
Develop and submit necessary documentation to support regulatory submissions.
Collaborate with regulatory affairs teams to ensure compliance throughout the trial process.

3. Lead Clinical Study Design and Protocol Development

Create clinical study protocols, ensuring they meet scientific, regulatory, and operational standards.
Design data collection strategies that align with the clinical goals and regulatory needs.
Collaborate with clinical researchers to refine study protocols and ensure feasibility.

4. Manage Clinical Data Analysis and Reporting

Oversee the collection, analysis, and interpretation of clinical data.
Prepare clinical study reports, ensuring data is accurate and compliant with regulatory requirements.
Present findings to internal and external stakeholders, including senior management and regulatory bodies.

5. Coordinate Cross-Functional Collaboration

Work closely with R&D, regulatory affairs, and quality assurance teams to ensure seamless project execution.
Provide clinical expertise and guidance to cross-functional teams during product development phases.
Ensure that clinical trial activities are integrated into the overall product development process.

6. Supervise Clinical Research Staff and External Partners

Manage clinical research associates (CRAs) and other clinical staff involved in trial activities.
Develop and foster strong relationships with external clinical research organizations (CROs) and investigators.
Ensure that all external partners comply with company standards and regulatory requirements.

7. Monitor Trial Budget and Resources

Oversee clinical trial budgets, ensuring resources are allocated efficiently.
Ensure that trials are conducted within budget constraints while maintaining quality and compliance.
Track expenditures and provide regular budget updates to senior management.

8. Drive Continuous Improvement in Clinical Affairs Processes

Identify and implement process improvements to enhance the efficiency and effectiveness of clinical trials.
Stay updated on industry best practices and incorporate new methodologies where appropriate.
Advocate for quality assurance and risk management in all clinical activities.

What The Client is Looking For in You
To succeed in the Senior Clinical Affairs Manager (Med Device) role in Raleigh, NC, you should bring a blend of clinical expertise, leadership skills, and experience in the medical device industry. The ideal candidate will have:

Extensive Experience in Clinical Affairs – A proven track record of managing clinical trials in the medical device field, including overseeing trial design, data collection, and regulatory compliance.
Regulatory Knowledge – Strong understanding of FDA regulations, ISO standards, and other relevant regulatory requirements for medical devices.
Leadership Skills – Experience leading teams and managing external partners such as clinical research organizations (CROs) to ensure trials are conducted smoothly and on time.
Strategic Thinking – The ability to design, plan, and execute clinical strategies that align with overall business objectives.
Strong Communication Skills – The capacity to communicate complex clinical findings to various stakeholders, including regulatory agencies, R&D teams, and senior management.
Attention to Detail – A meticulous approach to clinical trial design and execution, ensuring accuracy, compliance, and patient safety.
Problem-Solving Abilities – The ability to address challenges in trial management, including recruitment issues, budget constraints, and regulatory concerns.
Educational Background – A degree in life sciences, nursing, or a related field (advanced degrees preferred). Certifications in clinical research (e.g., CCRP) are a plus.

Why This Opportunity Stands Out
This role offers an exciting opportunity to join a forward-thinking medical device company that is committed to advancing patient care through innovative technologies. Here’s why this opportunity stands out:

Leadership Impact – As the Senior Clinical Affairs Manager, you will have the chance to lead clinical trials that directly impact the development of life-changing medical devices.
Career Growth – This position offers significant professional development opportunities in a rapidly evolving industry, with potential for career progression into senior leadership roles.
Collaboration with Experts – Work alongside experienced professionals in R&D, regulatory affairs, and quality assurance, ensuring you gain exposure to diverse aspects of the medical device development process.
Dynamic Work Environment – Join a company that values innovation, quality, and teamwork, fostering a collaborative culture where your contributions are highly valued.
Competitive Compensation – Along with a competitive salary, the position offers a comprehensive benefits package, including health, retirement plans, and performance-based incentives.
Impact on Healthcare – Your role will be pivotal in shaping the development and commercialization of medical devices that will improve patient outcomes globally.

FAQs About the Role
Q: Is relocation required for this position?A: The role is based in Raleigh, NC. Candidates must either be local or willing to relocate. A relocation package may be available for the right candidate.
Q: What type of clinical trials will I be managing?A: You will manage clinical trials for medical devices across various stages of development, including early-stage feasibility studies and late-stage pivotal trials.
Q: What are the key qualifications for this role?A: Candidates should have a background in clinical research, with experience in the medical device industry, regulatory knowledge, and a degree in a related field. A master’s or PhD is preferred, but not required.
Q: What leadership experience is required?A: The role requires proven leadership experience, including managing clinical research teams, external partners, and cross-functional collaboration with R&D and regulatory teams.
Q: What is the expected travel requirement for this role?A: Some travel may be required for site visits, regulatory meetings, and industry conferences. However, the majority of work will be based in Raleigh, NC.
Q: What regulatory knowledge is essential for this role?A: You should be well-versed in FDA regulations, ISO standards, and other relevant guidelines for conducting clinical trials for medical devices.
Q: How does this position contribute to the company’s goals?A: The Senior Clinical Affairs Manager will play a critical role in ensuring the success of clinical trials, which directly impacts the timely development and market approval of medical devices, driving the company’s growth and innovation.
Q: What is the timeline for hiring and onboarding?A: The company aims to fill this role within the next 60 days. Onboarding will involve training on internal processes, systems, and alignment with clinical and regulatory teams.
What Remuneration Can You Expect from This Job?
As the Senior Clinical Affairs Manager (Med Device) in Raleigh, NC, you can expect a competitive and comprehensive compensation package that reflects your level of experience and the critical nature of this role. The base salary for this position typically ranges from $120,000 to $160,000 annually, depending on your expertise, leadership experience, and the specific qualifications you bring to the table.
In addition to the base salary, you can expect performance-based bonuses that reward your success in driving clinical trials and achieving key milestones. These bonuses are aligned with both individual performance and company-wide objectives, ensuring that your contributions are recognized and rewarded.
The benefits package for this role is comprehensive, including health, dental, and vision insurance, a 401(k) plan with company matching, and generous paid time off. There may also be opportunities for professional development and additional certifications to support your career growth.
For those who need to relocate, a relocation package may be offered to ensure a smooth transition to Raleigh, NC. Equity options and stock grants may also be available for top candidates, providing an additional opportunity to benefit from the company’s long-term success.
How to Apply for This Senior Clinical Affairs Manager (Med Device) Position in Raleigh, NC
If you are a highly experienced clinical affairs professional with a passion for medical device development, we invite you to apply for the Senior Clinical Affairs Manager (Med Device) in Raleigh, NC. This is an excellent opportunity to contribute to the advancement of innovative medical technologies that make a direct impact on patient outcomes.
To apply, please submit your resume and a cover letter that details your experience in clinical trial management, regulatory compliance, and your leadership in the medical device industry.
This role offers a rewarding opportunity to shape the clinical strategy and contribute to the development of life-saving medical devices. Apply today to take the next step in your career as a Senior Clinical Affairs Manager (Med Device) in Raleigh, NC!
For more information or to explore similar opportunities, visit our Medical Device Recruiting page.
Tags: Senior Clinical Affairs Manager | Clinical Trials Manager | Medical Device Industry | Regulatory Affairs | Clinical Research | FDA Compliance | Medical Technology