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
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
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
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Quality Assurance and Product Management
Industries
Medical Equipment Manufacturing
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