Medical Product Development Subject Matter Expert

Company Description

BryceTech has partnered with technology and R&D clients to deliver mission and business success since 2017. Bryce combines core competencies in analytics and engineering with domain expertise. Our teams help government agencies, Fortune 500 firms, and investors manage complex programs, develop IT tools, and forecast critical outcomes. We offer clients proprietary, research-based models that enable evidence-based decision-making. Bryce cultivates a culture of engagement and partnership with our clients. BryceTech is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description

BryceTech is currently looking for a Medical Product Development Subject Matter Expert. This position will be supporting a high-visibility ASPR client managing over $12B in portfolio value with a variety of needs including support to the project team, acquisition program, and industry outreach efforts. This role will support the development and management of innovative government programs to expand the industrial base for public health sector medical technology.

The person in this role will:

• Support the ASPR Innovation efforts, to evaluate the merit and maturity of proposed medical technologies that will build a diverse, agile public health supply chain and sustain long-term U.S. manufacturing capabilities by investing in medical product Industrial Base Expansion capacities.
• Provide support as a regulatory and quality affairs SME on pathways for the successful review of planned and known ASPR procurements that require regulatory clearance through other agencies, such as the Food and Drug Administration (FDA);
• Advise on innovative regulatory and quality affairs approaches for the successful development, licensure, and manufacturing and distribution of drugs, medical devices and/or products, and therapeutics as required;
• Advise ASPR leadership on critical programmatic and project level regulatory challenges;
• Provide training and advisement to ASPR leadership on regulations, authoring regulatory documents, and interactions with regulatory authorities;
• Support the review White Papers and Full Proposals as required;
• Support the review of business systems and tools designed to support IBMSC;
• Travel on official business per the government’s request as required;Demonstrate proficiency with all MS Office products and Adobe Acrobat

Qualifications

• PhD in engineering, chemistry, or a related field
• 10+ years’ experience with pharmaceutical or regulated medical product development and FDA approval
• Experience with federal government acquisition programs.
• Excellent verbal and written communications skills
• Proficiency with all MS Office product and Adobe Acrobat

Additional Information

BryceTech offers a full range of benefits, including competitive salary, a comprehensive health plan including dental and vision coverage, company-paid life & disability insurance policies, 401(k) plan with company match, and an educational reimbursement program.

All your information will be kept confidential according to EEO guidelines.