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