Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is also focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.
We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.
Position Background:
We are searching for a Manager, Regulatory Affairs Labeling and Operations with a solutions oriented, roll-up-your-sleeves, attitude to join the Regulatory Affairs team, collaborate cross-functionally and externally with vendors. The individual for this position will be responsible for the compilation of labeling documents for all submissions which include labeling information to market Humacyte’s Human Acellular Vessel (HAV) in the US and worldwide. This position will also be accountable for completing tasks in regulatory operations.
Remote Work Designation: Onsite/Not Remote
Major Accountabilities:
Qualifications:
General Competencies:
Reports to work on time and as scheduled
Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is also focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.
We are looking for additional technically strong colleagues with intellectual curiosity, and a solutions focused mindset with the proven ability to solve problems from simple to complex to expand our team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and partner effectively with other professionals and peers.