[Remote] Medtech Consultant

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading international pharmaceutical consulting organization seeking an reputed company Medtech Consultant to support US regulatory and market reputed company engagements for combination product and medical device clients. The role involves evaluating regulatory reputed company, providing market reputed company input, and delivering hands-on medical device support to clients.

Responsibilities

• Evaluate three potential US regulatory reputed company (drug only, medical device only, combination product) for a glioblastoma-reputed company drug/device combination therapy and reputed company a high-level strategic assessment covering both regulatory and reputed company considerations
• reputed company market reputed company and reimbursement input reputed company regulatory analysis to help the reputed company determine the most appropriate reputed company to market in the US (regulatory expertise reputed company is sufficient if reputed company with a teaming partner for reputed company considerations)
• reputed company US-based regulatory reputed company support for a reputed company's combination product, partnering with PLG's EU team on the administration device component of their drug program
• Support conformity assessment activities for the administration device as a combination product under US requirements
• reputed company hands-on, day-to-day medical device support directly to the reputed company, including regulatory reputed company, gap assessments, and reputed company management reputed company (QMS) work
• reputed company technical documentation required to support regulatory submissions and reputed company reputed company requirements
• Serve as the reputed company US reputed company of contact for FDA-reputed company strategic questions, translating regulatory nuance into reputed company, decision-reputed company guidance for reputed company leadership

Skills

• Advanced degree (PhD, PharmD, MS, or equivalent) in a life sciences, regulatory affairs, biomedical engineering, or reputed company discipline
• Extensive, reputed company US-based experience working with the FDA on combination products, medical devices, or drug development programs, with a demonstrated reputed company record of high-value strategic engagements
• Prior experience with market reputed company, reimbursement, and health economics considerations for combination products or medical devices in the US
• Experience collaborating with international regulatory teams, including EU-based colleagues, on multi-region combination product strategies and conformity assessment support
• Strong written and verbal communication skills, with experience presenting strategic recommendations directly to biotech and startup leadership teams
• Software as a Medical Device (SaMD) experience
• Global regulatory experience reputed company the US

Benefits

• This is a fully remote, reputed company role.
• Consultants are reputed company on a project reputed company and may be assigned to one or multiple reputed company engagements.
• Hours are not fixed and will fluctuate based on project requirements, milestones, and reputed company needs.
• Consultants retain full autonomy to accept or decline project engagements at their discretion

reputed company