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Join to apply for the Regulatory Affairs Manager role at Capstan Medical

Reports to: Head of Regulatory Affairs (SVP, RA)

Workplace type: Hybrid

Description

This is a unique opportunity for an experienced Regulatory Affairs professional to join a well-funded, early-stage start-up positioned to revolutionize structural heart care. The Manager of Regulatory Affairs will help build and execute the regulatory strategy for our novel implant, catheter, and robotic platform products. This is a high-impact, hands-on role participating in the product development team and in the evaluation, preparation, compiling, and submitting of documentation for clinical studies and product registration.

Responsibilities

• Establish, communicate, and execute the regulatory strategy in partnership with leadership, product, and clinical teams.
• Prepare, review, and submit high-quality and accurate clinical study documents, including IDE, and Pre-Market Approval documents (510(k)s, IDEs, HUDs, PMAs, etc.) in collaboration with the team.
• Work with international affiliates to compile and submit international clinical study documents, product registrations and licensing applications.
• Review product design, quality, and manufacturing changes to assess regulatory impact and complete any associated regulatory activities.
  
  

• Experience in Class 3 implantable devices, cardiovascular implants is strongly preferred.
• Ability to work collaboratively in a fast-paced environment while managing multiple priorities, identifying critical path activities, and articulating/mitigating risks.
• Strong working knowledge of FDA Regulations and country-specific regulations; experience with ICH Guidelines and GCPs governing the conduct of clinical trials.
• Clear and effective communication skills with diverse audiences and personnel, both verbal and written.
• Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team.
• Proficiency in MS Word, Excel, Adobe, Power Point, and other systems as needed to ensure effective internal and external communication and to manage accurate/complete submissions.
  
  

• BS Degree in a scientific discipline; MS degree is a plus.
• Minimum of 8 years of regulatory experience in the medical device industry; 6 years with a Masters degree; 4 years with a Doctorate.
• Experience with effectively managing and growing team(s).
  
  

• We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space that can make a meaningful impact for patients.
• We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.
• We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you'd like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!
  
  

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Medical Equipment Manufacturing

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