Regulatory Affairs Lead Specialist (Fixed-Term Contract – Maternity Cover)
About the Opportunity
A global MedTech organization developing innovative medical devices is looking for a Regulatory Affairs Lead Specialist to support international regulatory activities during a maternity cover period.
This role will play a key part in driving regulatory strategy and submissions across global markets, working closely with cross-functional teams to ensure compliance and timely product approvals.
Key Responsibilities
- Lead global regulatory projects to secure market authorization and promotional approvals for medical devices
- Develop and implement regulatory strategies aligned with business objectives, including target markets, clinical claims, and timelines
- Define testing and clinical study requirements to support regulatory submissions
- Prepare and submit regulatory dossiers across global markets (US, Europe, Canada, LATAM, Asia, China)
- Provide regulatory guidance throughout the product development lifecycle
- Assess design changes and determine regulatory impact and submission requirements
- Review and approve promotional materials to ensure compliance with regulatory claims
- Monitor regulatory trends and updates, ensuring internal alignment
- Support audits and inspections as required
Profile
- Strong experience in Regulatory Affairs within the medical device industry
- Solid understanding of global regulatory frameworks and submission processes
- Strong analytical, problem-solving, and project management skills
- Excellent communication skills, both written and verbal
- Fluency in English
Preferred Experience
- Experience interacting with global regulatory authorities (e.g. FDA, Notified Bodies, NMPA)
- Knowledge of Quality Management Systems (QMS) and regulatory compliance frameworks
- Ability to work independently in a dynamic, fast-paced environment