Senior Manager – Regulatory Affairs

Overview

We are partnering with a global medical device organisation to recruit a Senior Manager of Regulatory Affairs. This is a senior leadership role supporting a diverse portfolio of medical device products across global markets.

The successful candidate will play a critical role in defining and executing regulatory strategy, leading regulatory submissions, assessing regulatory impact of product changes, and developing a high-performing regulatory team. This position requires strong cross-functional collaboration and the ability to operate effectively in a complex, highly regulated environment.

Key Responsibilities

Regulatory Strategy & Product Development

• Develop and implement global regulatory strategies across the full product lifecycle, from R&D through commercialisation and post-market activities
• Partner with R&D, clinical, quality, operations and marketing teams to ensure regulatory requirements are embedded into development plans and timelines
• Provide regulatory guidance on product submissions (e.g. 510(k), technical documentation, lifecycle submissions)

Market Access & Regulatory Submissions

• Oversee preparation, review and submission of regulatory filings in the US and EU
• Act as the primary regulatory liaison with authorities such as the FDA and Notified Bodies
• Support resolution of regulatory questions and issues to enable timely approvals

Team Leadership & Development

• Lead and allocate regulatory resources across assigned product programs
• Build, mentor and develop regulatory professionals, supporting career development and capability growth
• Provide coaching and technical guidance on complex regulatory matters

Risk Management & Compliance

• Identify regulatory risks and contribute to mitigation strategies
• Monitor changes in global regulatory requirements and communicate impacts to stakeholders
• Ensure ongoing compliance throughout the product lifecycle

Business & Strategic Initiatives

• Provide regulatory input into business initiatives, new ventures and partnerships
• Support regulatory due diligence activities as required

Skills & Experience

• Degree (Level 8 or equivalent) in a scientific or engineering discipline with 7+ years’ experience in medical device regulatory affairs, including 5+ years in a leadership, management, or mentorship capacity
  or
• Advanced degree with 5+ years’ experience in medical device regulatory affairs, including leadership responsibilities
• Proven experience leading regulatory teams and aligning regulatory strategy with business objectives
• Strong knowledge of the global medical device regulatory landscape
• Experience supporting products from concept through commercialisation and post-market phases
• Demonstrated business acumen within a regulated environment
• Experience driving process improvement and change initiatives
• Strong analytical skills with the ability to use data to inform regulatory decisions
• Excellent communication, stakeholder management and influencing skills