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.
Skills:
- 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.
Requirements:
- 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).
Why join us:
- 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!
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.