Senior Regulatory Affairs Specialist — Software

Job overview

The Senior Regulatory Affairs Specialist — Software role is described as flexible remote or hybrid onsite in Madison, NJ; compensation is not specified. The specialist supports OrganOx’s regulatory department and its medical-device and organ-technology work. The role may require up to 5% domestic or international travel. The role supports compliant development and commercialization by preparing regulatory submissions, advising assigned digital health and device projects, coordinating with cross-functional teams and regulators, assessing regulatory changes, and communicating applicable requirements and standards.

What you'll do

• Support regulatory affairs for digital health, software, cybersecurity, electromechanical devices, and regulatory intelligence
• support pre-market and post-market activities
• prepare submissions for FDA and Health Canada
• interface with regulators and respond to information requests
• monitor regulatory requirements and standards
• communicate regulatory changes
• perform regulatory change assessments
• review guidance and standards for compliance
• prepare visualizations and conclusions for management
• work with stakeholders and follow company policies.

What we're looking for

Skills & competencies

senior regulatory affairs specialist

software

remote or hybrid

madison nj

organox

medical devices

digital health

software as a medical device

cybersecurity

fda submissions

health canada

up to 5% travel

Work arrangement

• Weekend coverage required

Benefits & perks

• Health, dental, vision, and disability coverage
• flexible spending accounts
• 401(k) with company match after 90 days
• paid time off, holidays, and additional leave
• employee discounts
• onsite wellness facility
• professional development.

Why this role

The posting describes the work arrangement as flexible remote or hybrid onsite in Madison, NJ, with up to 5% travel domestically or internationally.

About the employer

OrganOx is hiring for this role. Industry: Surgical and Medical Instrument Manufacturing. Sector: 33.