Scientific Affairs Associate Jobs

The Position:

MACH32 is looking for a motivated Scientific Affairs Associate to join our dynamic team.The successful candidate will play a key role in developing and commercializing innovative medical technologies.This diverse role will expose the successful candidate to a wide range of product development, regulatory, quality and business development activities. MACH32 is a start-up company; this is an entry level position but carries a huge opportunity for a broad range of responsibilities and growth.

Key Responsibilities:

Product Development

oWork with MACH32’s product development team to commercialize MACH32’s lead product, IMSAFE

oActivities could include: testing IMSAFE prototype devices, collecting end-user feedback to ensure usability of IMSAFE, designing and testing instructions for use and training materials, maintaining competition database, maintaining documentation

Regulatory and Quality Affairs

oWork with the MACH32 internal and external regulatory affairs team to develop strategic regulatory plans

oSupport preparation of MACH32’s regulatory submissions, including Investigational New Drug (IND) and CTA (Clinical Trial Applications)

oManage controlled documents in accordance with MACH32’s standard operating procedures

Scientific and Technical Writing

oDevelop and write standard operating procedures to support MACH32’s quality management system and operations.

oPrepare technical reports, presentations, grant applications, and research articles/presentations; this includes poster and PowerPoint presentations.

Project Management

oManage the delivery of projects, as assigned by the COO, including both internal and customer-facing.

oDevelop project budgets to ensure project objectives are met

Business Development and Marketing

oSupport MACH32’s marketing effort by preparing scientific materials for presentation at conferences, customer, and investor meetings.

oCoordinate MACH32’s presence at scientific conferences, including managing booths and interacting with potential customers.

Skills & Qualifications:

·B.Sc. in Science (or related discipline, such as pharmacology, biomedical engineering, biology); M.Sc. preferred.

·Eager to work in a fast-paced startup environment. Honest, hardworking, and adaptable to changing tasks and roles.

·Excellent oral & written communication skills and ability to effectively communicate across multiple stakeholders, both internal and external to the organization.

·Self-motivated, able to set and achieve goals for individual projects.

·Ability to work independently with little direction.

·Team focused. Your tasks will change on a regular basis and often you will be supporting other team members on larger projects.

·Strong organizational skills and attention to detail required for document control and quality affairs work.

·Experience with Microsoft PowerPoint, Excel, Word, Adobe.

·Can accept constructive criticism but is also comfortable speaking up. Our work environment is designed to be less hierarchical and more responsive to the best ideas. More responsibility but also more opportunity!

·Willing to work non-traditional shifts, such as evenings or weekends, on an as needed basis.

·Experience working on a medical device, pharmaceutical or combination product preferred.

Closing Date and Contact:

Resumes and cover letter must be received by September 8^th, 2023 to:

Kelly Mottet

[email protected]