
Regulatory Affairs – Post-market Consultant
3 weeks ago
We're currently seeking a Regulatory Affairs Consultant to support our Post-Market Compliance efforts on a short-term, part-time basis during a critical period for the team.This is an excellent opportunity for an experienced regulatory professional to contribute meaningfully to Res Med's mission by ensuring continued product compliance across global markets.About The RoleAs a Post-Market Consultant in the Regulatory Affairs team, you'll work across a variety of post-market regulatory activities to help maintain compliance for Res Med's marketed medical devices.
You'll collaborate with stakeholders across Quality, Product Development, and Global Product Management, providing regulatory input, delivering key assessments, and supporting ongoing product lifecycle activities.What You'll Be DoingRepresent Regulatory Affairs on selected post-market cross-functional teams Prepare and implement post-market regulatory assessments (e.g., FDA, TGA, EU Notified Bodies) Support medical device reporting (MDR) and post-market surveillance activities Monitor updates to global regulatory standards (FDA, EU MDR, ISO, IEC) and ensure alignment Assist with special projects to support business continuity and compliance What You'll BringA degree in Engineering, Science, or a related field 6+ years' experience in medical device regulatory affairs Hands-on experience with post-market regulatory activities Excellent documentation, organizational, and stakeholder communication skills Comfortable working independently in a flexible, part-time consultancy model Nice-to-Have: Familiarity with EU MDR post-market surveillance and ISO 13485 Experience working across multiple global markets (e.g., US FDA, TGA, EU) Ability to quickly adapt and prioritize tasks in a dynamic environment Engagement DetailsPart-time (3 days/week)6-month contractRemote WorkImmediate start preferredJoining us is more than saying "yes" to making the world a healthier place.
It's discovering a career that's challenging, supportive and inspiring.
Where a culture driven by excellence helps you not only meet your goals, but also create new ones.
We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates.
If this sounds like the workplace for you, apply now Seniority level Seniority level Mid-Senior level Employment type Employment type Part-time Job function Job function Consulting, Information Technology, and Sales Industries Software Development, IT Services and IT Consulting, and Medical Equipment Manufacturing Referrals increase your chances of interviewing at Resmed by 2x Sign in to set job alerts for "Market Consultant" roles.
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