Are you an experienced regulatory professional with a deep understanding of medical device regulations? We are seeking a Regulatory Affairs Manager (Medical Device) in Charlotte, NC, to lead the regulatory strategy for a growing medical device company. This role offers an exciting opportunity to manage compliance, support product approvals, and work closely with cross-functional teams to ensure timely regulatory submissions. If you’re looking to make an impact in the medical device industry, this is the perfect position for you.
About The Role
As the Regulatory Affairs Manager (Medical Device) in Charlotte, NC, you will oversee the regulatory affairs department, ensuring that all products comply with FDA, ISO, and international regulations. You will work closely with product development teams, ensuring that new medical devices meet all regulatory requirements from concept to market. This role requires someone with a strategic mindset who can navigate complex regulatory pathways while maintaining a high level of compliance and efficiency. If you’re ready to drive regulatory success in the medical device industry, we encourage you to apply.
Key Responsibilities – Regulatory Affairs Manager (Medical Device) in Charlotte, NC
1. Oversee Regulatory Submissions and Approvals
- Manage and prepare regulatory submissions to the FDA, including 510(k), PMA, and IDE applications.
- Collaborate with product development teams to ensure timely and accurate submissions.
- Ensure regulatory submissions comply with all applicable regulations and standards.
2. Develop and Implement Regulatory Strategy
- Create and implement regulatory strategies for new product development and market entry.
- Advise senior leadership on regulatory risks and provide recommendations for mitigation.
- Ensure that regulatory strategies align with company business objectives and timelines.
3. Ensure Compliance with Regulatory Standards
- Monitor and maintain compliance with all regulatory requirements, including FDA, ISO, and international standards.
- Conduct regular audits to identify potential compliance issues and address them proactively.
- Stay updated on changes in regulations and guidelines that impact medical device products.
4. Support Product Lifecycle Management
- Oversee the regulatory aspects of product lifecycle management, from design through post-market surveillance.
- Coordinate regulatory activities related to design changes, labeling updates, and manufacturing processes.
- Collaborate with quality control and assurance teams to ensure product compliance.
5. Regulatory Risk Assessment and Mitigation
- Conduct regulatory risk assessments for new products and modifications.
- Develop strategies to mitigate potential regulatory risks and ensure product approval.
- Provide expert guidance on navigating complex regulatory environments in multiple regions.
6. Provide Regulatory Guidance to Cross-Functional Teams
- Collaborate with R&D, marketing, and operations teams to ensure compliance in product design and development.
- Provide guidance on regulatory requirements for clinical trials, labeling, and advertising.
- Serve as the primary point of contact for regulatory questions and concerns.
7. Maintain Regulatory Documentation and Records
- Ensure that all regulatory filings and documents are properly maintained and easily accessible.
- Create and manage regulatory submissions, reports, and documentation for internal and external audits.
- Ensure accurate documentation of regulatory communications and approvals.
8. Lead Regulatory Affairs Initiatives and Training
- Lead regulatory affairs initiatives to improve efficiency and compliance within the organization.
- Develop and deliver training programs for staff on regulatory requirements and best practices.
- Foster a culture of compliance across the company by keeping the team informed of changes in regulations.
What The Client is Looking For in You
To succeed as the Regulatory Affairs Manager (Medical Device) in Charlotte, NC, the ideal candidate should bring a mix of technical expertise, regulatory knowledge, and leadership skills. The client is looking for someone who has:
- Strong Regulatory Knowledge: A deep understanding of FDA regulations, ISO standards, and international regulatory requirements for medical devices.
- Proven Experience in Medical Device Regulatory Affairs: At least 5-7 years of experience in regulatory affairs in the medical device industry, with a track record of successful FDA submissions and product approvals.
- Strategic Thinking and Problem Solving: Ability to develop and implement regulatory strategies for product development, ensuring compliance while optimizing time-to-market.
- Excellent Communication Skills: The ability to communicate complex regulatory information clearly to cross-functional teams, senior leadership, and external partners.
- Detail-Oriented: A keen eye for detail and the ability to manage multiple regulatory tasks, from submissions to documentation and compliance assessments.
- Leadership and Team Collaboration: Ability to lead regulatory initiatives and mentor junior staff while working collaboratively with product development, quality assurance, and marketing teams.
- Regulatory Risk Management Skills: Proficiency in assessing regulatory risks and developing mitigation strategies to keep product development on track.
- Adaptability: Ability to quickly adapt to changing regulations and industry trends, maintaining a proactive and flexible approach to compliance.
Why This Opportunity Stands Out
This is a unique opportunity to step into a pivotal role with a growing medical device company that is committed to innovation and regulatory excellence. Here’s why this role stands out:
- Impactful Role: As the Regulatory Affairs Manager (Medical Device), you will play a key part in the company’s growth by ensuring that all products meet regulatory requirements from the ground up.
- Leadership Opportunity: This is a leadership role where you will have the chance to guide regulatory strategies and collaborate with cross-functional teams across the organization.
- Industry Growth: The medical device industry is one of the most rapidly evolving sectors, and this role offers the chance to work on cutting-edge products in a dynamic environment.
- Competitive Compensation and Benefits: The role offers an attractive salary package along with health benefits, retirement plans, and other perks.
- Growth and Learning: You will be part of an expanding team where there is ample opportunity for professional development and career advancement.
FAQs About the Role
Q: What experience is required for this role?
A: The ideal candidate will have 5-7 years of experience in regulatory affairs within the medical device industry, with a proven record of FDA submissions and product approvals.
Q: Is relocation required for this position?
A: Yes, this position is based in Charlotte, NC. Candidates must either be local or willing to relocate. A relocation package may be available for the right candidate.
Q: What qualifications are required?
A: A bachelor’s degree in life sciences, engineering, or a related field is required. A master’s degree in regulatory affairs or a similar field is a plus. Certification through RAPS (Regulatory Affairs Professionals Society) is also beneficial.
Q: What are the key responsibilities of this role?
A: The main responsibilities include managing regulatory submissions, overseeing compliance, developing regulatory strategies, guiding cross-functional teams, and ensuring adherence to FDA, ISO, and international regulations.
Q: Will there be any travel required for this role?
A: Some travel may be required, primarily for regulatory meetings or industry conferences. However, most of the role’s duties will be based in Charlotte, NC.
Q: What kind of leadership is expected in this role?
A: The ideal candidate should be a proactive, detail-oriented leader who can work collaboratively with various departments and drive regulatory strategy across the organization.
Q: How does this role contribute to the company’s success?
A: As the Regulatory Affairs Manager (Medical Device), you will ensure that all products meet regulatory standards, enabling the company to introduce innovative medical devices to the market while maintaining compliance with regulatory authorities.
Q: What is the timeline for hiring and onboarding?
A: The company aims to fill this position within 60–90 days. The onboarding process will include in-depth training on the company’s products and regulatory processes, along with meetings with key departments.
What Remuneration Can You Expect from This Job?
As the Regulatory Affairs Manager (Medical Device) in Charlotte, NC, you can expect a competitive compensation package that reflects your expertise and the significant impact you’ll have on the company’s regulatory strategy. The base salary for this role typically ranges from $100,000 to $130,000 per year, depending on your experience, qualifications, and regulatory expertise within the medical device industry.
In addition to the base salary, this position offers performance-based bonuses, which are tied to key milestones such as successful regulatory submissions, market approvals, and product compliance achievements. You may also be eligible for stock options or equity, providing you with the opportunity 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, paid time off (PTO), and other executive-level perks such as travel allowances, professional development opportunities, and potential relocation support. These benefits are designed to ensure that you have the resources and support needed to thrive both professionally and personally.
This role provides not only a lucrative financial package but also the chance to grow within a dynamic and fast-paced environment at the forefront of the medical device industry.
How to Apply for This Regulatory Affairs Manager (Medical Device) Position in Charlotte, NC
If you are a highly motivated and experienced regulatory affairs professional with a proven track record in medical device compliance, we invite you to apply for the Regulatory Affairs Manager (Medical Device) position in Charlotte, NC. This is a fantastic opportunity to play a pivotal role in shaping the company’s regulatory strategy and ensuring the successful market entry of cutting-edge medical devices.
To apply, please submit your resume along with a cover letter that outlines your experience in regulatory affairs, including your work with FDA submissions, ISO standards, and other industry regulations. In your cover letter, highlight your leadership experience and your ability to collaborate across teams to drive regulatory success.
This position offers the opportunity to make a real impact in the medical device industry and work with an innovative team committed to excellence. Apply today to take the next step in your regulatory affairs career!
For more information or to explore similar opportunities, visit our Medical Device Recruiters page.
Tags: Regulatory Affairs Manager | Medical Device Regulatory | FDA Submissions | Regulatory Compliance | Medical Device Jobs | ISO Standards
