Medical Affairs Manager (Medical Devices)

TL;DR

Medical Affairs Manager (Medical Devices): Serving as a clinical and scientific expert to engage with healthcare professionals and provide scientific expertise throughout the product life cycle with an accent on regulatory compliance and scientific exchange. Focus on authoring technical documentation, managing clinical evaluations, and collaborating with cross-functional global teams to ensure product safety and effectiveness.

Location: Wayne, NJ, US (Hybrid: 3-4 days at home)

Salary: $130,000 – $150,000 plus 15% bonus

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows in intensive care, cardiovascular procedures, and operating rooms.

What you will do

• Engage in scientific exchange with thought leaders and healthcare professionals (HCPs) to enhance disease state education and research.
• Provide medical and technical subject matter expertise for regulatory submissions and scientific communications.
• Collaborate with cross-functional teams on product development, risk management, and clinical marketing.
• Monitor literature and maintain in-depth knowledge of clinical landscapes and trends to support product lines.
• Author technical documentation such as SOPs, medical assessments, and health hazard evaluations.
• Contribute to product risk management by identifying clinical risks and evaluating adverse events.

Requirements

• Bachelor’s Degree in Science with minimum 8 years of relevant experience, OR an Advanced Scientific Degree with minimum 5 years of relevant experience.
• Must be based in or able to work from Wayne, NJ.
• Proven understanding of the medical device industry and healthcare system requirements.
• Knowledge of regulatory requirements, compliance standards, and ethical obligations.
• Ability to communicate effectively within a global matrix organization and with medical research staff.
• Strong verbal, written, and presentation skills.

Nice to have

• Medical writing experience and experience implementing standard operating procedures.
• Solid understanding of FDA and Global Regulatory Authority policies regarding medical device companies.
• Experience developing medical communications and educational content for various stakeholders.

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance benefits.
• 401k plan with company match.
• Paid Time Off and Wellness initiative & Health Assistance Resources.
• Life Insurance, Short and Long Term Disability Benefits.
• Health and Dependent Care Flexible Spending Accounts and Commuter Benefits.
• Parental and Caregiver Leave and Tuition Reimbursement.