Strategic Regulatory Product Leader

Job Title: Strategic Regulatory Product Leader

This is a key role for an experienced Regulatory Affairs professional who will oversee regulatory execution for products manufactured under the legal entity.

The successful candidate will lead a team responsible for shaping and delivering global regulatory strategies that span concept through launch and ensuring successful navigation of global regulatory pathways.

• Strategic & Operational Leadership

Lead RA strategy and delivery for NPI projects owned by the legal manufacturer, PLE projects owned by the legal manufacturer and Singapore legal manufacturer (e.g., masks, devices, accessories).

Define regulatory pathways and ensure submission planning aligns with market access timelines and business needs.

Guide the development of design input requirements, verification strategies, and risk documentation that meet global regulatory expectations (e.g., 510(k), CE Mark, TGA, MDSAP).

Elevate risks, resource constraints, or submission delays proactively and constructively, in line with the RA escalation model.

• Cross-Functional Collaboration

Support the team and be the RA representative on product XFTs originating from the legal manufacturer.

Promote alignment with key functions such as systems engineering, quality, project management, operations, clinical, and marketing.

Ensure early RA input and engagement during design reviews, change planning, and design control phases.Regulatory Strategy & Submission Oversight

Oversight the development and delivery of high-quality regulatory submissions globally, including US FDA, EU MDR, TGA, and other priority markets.

Review and approve key submission components and assessments, including Design Change Assessments (DCAs), risk-benefit documentation, and labelling claims.

Ensure documentation is submission-ready and aligned with quality system, global templates, and timelines.People Leadership & Team Development

Lead and coach a team of regulatory professionals, supporting career development, onboarding, and performance management.

Foster a high-trust, inclusive culture that emphasizes accountability, regulatory excellence, and continuous learning.

Support Individual Development Plans, mentoring structures, and knowledge sharing within the team and the broader RA function.Process Excellence & System Stewardship

Drive improvements to regulatory workflows, including Jira tracking, RIMSYS submissions, and Confluence knowledge management.

Ensure the team uses consistent processes, applies global templates, and adheres to design control and submission SOPs.

Collaborate with the Regulatory Foundations and Digitalization teams to enhance submission logistics, tools, and dashboards.Qualifications & Experience

• Bachelor's degree (or higher) in biomedical engineering, life sciences, regulatory affairs, or a related discipline.
• 6+ years in Regulatory Affairs, with 2+ years in a leadership or mentoring capacity.
• Proven experience supporting device submissions (e.g., FDA 510(k), CE MDR, TGA ARTG).
• Excellent knowledge of ISO 13485, ISO 14971, 21 CFR 820, and other applicable standards.
• Experience working on design and development teams under design control processes.
• Strong organizational and time management skills; ability to lead multiple concurrent priorities.
• Clear, structured communicator with experience influencing cross-functional partners and regulatory authorities.

Preferred qualifications include prior experience leading RA strategy for a legal manufacturer or global product line, experience with Jira, Confluence, and RIMSYS (or equivalent regulatory systems), familiarity with digital health components (e.g., connectivity, software in devices), and project management certification or training.

This role offers opportunities for personal and professional growth. You'll work closely with senior leaders and stakeholders to deliver strategic plans and achieve key objectives.

You'll have the autonomy to develop your own solutions, prioritize your tasks and manage multiple projects simultaneously.

Join our organization and contribute to a collaborative environment where innovation, creativity and professionalism thrive.