About the company:
We’re at the center of both the data-driven revolution and the online health movement with consumers rapidly shifting to digital channels and increasingly taking their health into their own hands, we believe that improving the consumer healthcare industry starts with growing individual companies and businesses with technology and data.
Job Summary
We are seeking an experienced Senior Regulatory Manager specializing in Class I Medical Devices compliance across global markets (US, EU, Canada, UK, Australia, and other international markets).
This role involves leading regulatory initiatives, ensuring compliance with international regulations, and supporting market entry strategies for Class I medical devices.
The ideal candidate will have deep expertise in global Class I medical device regulatory frameworks, including:
FDA (21 CFR Part 820, QSR
EU MDR (Regulation (EU) 2017/745) and CE Marking
Health Canada MDEL requirements
UK MDR 2002 and UKCA Marking
TGA (Australia)
The role will require strategic regulatory leadership, cross-functional collaboration, and engagement
with regulatory authorities to maintain compliance across multiple jurisdictions.
Key Responsibilities:
Regulatory Compliance & Strategy
- Monitor and interpret Class I medical device regulations, industry trends, and compliance updates across multiple jurisdictions.
- Develop and implement regulatory strategies for Class I medical devices to meet market entry requirements.
- Ensure compliance with ISO 13485, Good Manufacturing Practices (GMP), risk management standards (ISO 14971), and QMS regulations in various regions.
- Provide regulatory guidance for device classification, risk assessments, conformity assessments, and safety evaluations for Class I medical devices.
Product Compliance & Market Entry Support
- Manage regulatory submissions, technical documentation, and device registrations for Class I medical devices, including:
o US FDA Establishment Registration and Device Listing
o EU MDR compliance, including Technical Documentation for CE Marking and any External Body interactions (if applicable)
o Health Canada MDEL registration and post-market compliance
o UK CA Marking requirements & Compliances
o TGA Class I medical device listing (ARTG registration)
- Review and approve device labels, IFUs, packaging, and marketing materials for regulatory compliance.
- Collaborate with teams/ suppliers to ensure product designs meet global regulatory standards.
- Oversee post-market surveillance (PMS), vigilance reporting, and adverse event monitoring as required for Class I medical devices.
Stakeholder Engagement & Audits
- Act as the primary liaison with regulatory agencies, bodies, third-party testing labs, and industry.
- Support internal and external audits, inspections, and regulatory inquiries from government authorities.
- Conduct regulatory training sessions for cross-functional teams to enhance compliance awareness.
Regulatory Intelligence & Risk Management
- Continuously track and analyze changes in Class I medical device legislation, standards, and enforcement actions.
- Identify potential regulatory risks and implement proactive mitigation strategies.
- Lead regulatory impact assessments for product modifications, recalls, and regulatory updates.
Key Requirements: Qualifications & Experience
Education & Experience
- Minimum Bachelor’s degree in a related field.
- 5+ years of regulatory experience in Class I medical device compliance across US, EU, UK, Canada, Australia, and global markets.
- Proven experience in medical device submissions, QMS implementation, and regulatory compliance management.
- Familiarity with ISO 13485, MDSAP, FDA 21 CFR Part 820, TGA requirements, and global medical device directives.
Skills & Competencies
- Strong knowledge of global Class I medical device regulations, classification, and approval pathways.
- Excellent analytical, problem-solving, and project management skills.
- Ability to interpret complex regulatory texts and communicate compliance strategies effectively.
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint) and regulatory compliance software.
- Effective verbal and written communication skills for cross-functional collaboration.
- Ability to work independently in a remote setting while coordinating with global teams.
Preferred Qualifications
- Experience with post-market surveillance, risk management, and clinical evaluations.
- Knowledge of UDI requirements, cybersecurity regulations, and regulatory intelligence tools. Professional certifications
- Knowledge of Slack, Zoom.
**ALL APPLICANTS ARE REQUIRED TO SUBMIT A BRIEF VIDEO INTRODUCTION.**
Purpose: This video will be sent to the client for a more efficient screening process.