AMF Consulting is partnering with a leading medical device organisation to recruit a Senior Manager of Regulatory Affairs to support a diverse portfolio of Acute Care & Monitoring products.
This is a senior leadership role with responsibility for shaping and executing regulatory strategies across the full product lifecycle. You will lead and develop a high-performing regulatory team, ensure global regulatory compliance, and work closely with cross-functional stakeholders to support product innovation and commercial success.
The Role
As Senior Manager of Regulatory Affairs, you will play a pivotal role in driving regulatory excellence while supporting business objectives in a highly regulated environment.
Key Responsibilities
Regulatory Strategy & Product Development
- Develop and implement global regulatory strategies from R&D through commercialisation and post-market activities
- Provide regulatory guidance on product submissions (e.g. 510(k), technical documentation, etc.)
- Partner with R&D, Clinical, Operations and Marketing to embed regulatory requirements into development plans and timelines
Market Access & Regulatory Submissions
- Oversee preparation, review and submission of regulatory filings in the US and EU
- Act as a key point of contact with regulatory authorities (e.g. FDA, Notified Bodies)
- Support product approvals and resolution of regulatory issues
Team Leadership & Development
- Lead and mentor regulatory professionals across assigned product programmes
- Align resources with departmental and business priorities
- Support talent development, succession planning and capability building within the team
Risk Management & Compliance
- Identify potential regulatory risks and contribute to mitigation strategies
- Stay current on regulatory changes and emerging trends, providing proactive guidance to stakeholders
Business & Strategic Initiatives
- Provide regulatory input into business initiatives, partnerships and due diligence activities
- Support long-term regulatory and commercial strategy
Key Skills & Experience
- Level 8 degree in a Scientific or Engineering discipline
- Minimum 7 years’ experience in medical device regulatory affairs, with 5+ years in a leadership, management or mentorship capacity
OR
- Advanced degree with 5+ years’ experience in medical device regulatory affairs and demonstrated leadership experience
- Strong knowledge of the global medical device regulatory landscape
- Experience supporting products through the full lifecycle, including post-market activities
- Proven people leadership and stakeholder management skills
- Strong business acumen within a regulated environment
- Experience supporting process improvement and change initiatives
- Excellent communication, influencing and collaboration skills