Principal Medical Affairs

The Principal, Medical Affairs role provides strategic medical/scientific support for the designated product platforms - integrating knowledge of business & functional priorities to address complex problems and non‑standard situations. As a key contributor in a complex environment, this position works independently with minimal guidance, sharing expertise as they represent Medical Affairs on Innovation and New Product Development Teams.

• Own and drive medical and scientific work streams for assigned products and pipeline assets, with responsibility for execution and delivery
• Lead the design, execution, and interpretation of clinical and pre‑clinical studies to support product development, regulatory approval, and market adoption
• Translate medical strategy into actionable evidence generation plans
  , aligned to business and innovation priorities
• Partner with R&D to integrate clinical insight into product development and design decisions
• Collaborate with Regulatory Affairs to shape clinical and non‑clinical evidence strategies supporting global submissions (e.g., IDE/PMA)
• Serve as the Medical Affairs representative on cross‑functional teams
  , influencing decisions across Clinical Affairs, R&D, Regulatory, Quality, and Marketing
• Contribute to scientific exchange activities
  , including interactions with key opinion leaders, investigators, and external stakeholders
• Ensure alignment with risk management and product safety considerations across the product lifecycle
• Drive evidence readiness and data generation strategies supporting both development and commercialization

• Functions as a senior individual contributor (no direct reports) with ownership of defined programs, products, or evidence portfolios
• Leads work independently
  , with minimal oversight, and is accountable for end‑to‑end execution of deliverables
• Influences cross‑functional teams without formal authority
• Contributes to medical strategy development while focusing on execution excellence and scientific leadership within scope

• Bachelor's degree in a scientific, medical, or engineering discipline required
• 4 years of relevant industry experience in medical device or biotechnology
• Demonstrated experience supporting or owning clinical or pre‑clinical studies (design through execution and analysis)
• Proven ability to operate independently and manage complex projects with minimal supervision
• Strong understanding of evidence generation in support of product development and regulatory pathways
• Excellent written and verbal communication skills, including the ability to convey complex scientific information clearly
• Experience in Medical Affairs with exposure to evidence strategy development
• Familiarity with Regulatory Affairs processes
  , including FDA or global submission requirements
• Knowledge of risk management for and medical devices safety principles
• Experience supporting or working within New Product Development (NPD) environments
• Able to work successfully in a fully remote office environment

• Advanced degree strongly preferred (PhD, MS)

• Clinical Scientist / Clinical Research Scientist (medical device or pharma)
• Medical Affairs Specialist or Associate with strategy and evidence generation exposure
• Medical Science Liaison with involvement in NPD, innovation, or medical strategy
• Clinical Research roles with demonstrated study ownership and cross‑functional collaboration
• Experience in scientific exchange
  , including KOL engagement or advisory board participation
• Experience managing external partners (e.g., CROs, investigators)

• Medical coverage, Health Savings Accounts, Flexible Spending Accounts, Dental coverage, Vision coverage, Hospital Care Insurance, Critical Illness Insurance, Accidental Injury Insurance, Life and AD&D insurance, Short‑term disability coverage, Long‑term disability insurance, Long‑term care with life insurance.
• Anxiety management program, wellness incentives, sleep improvement program, diabetes management program, virtual physical therapy, emotional/mental health support programs, weight management programs, gastrointestinal…