Core Diagnostics Regulatory Affairs Managers
On-sitePorto, Porto, Portugal
Job Summary
Develop and execute regulatory strategies for new product launches, product changes, and lifecycle management activities to ensure successful commercialization in global markets. Assess regulatory impact of product, manufacturing, supplier, and software changes, providing recommendations to support implementation and market continuity. Serve as the primary Regulatory Affairs point of contact for the manufacturing site, guiding site leadership and cross-functional stakeholders on compliance matters. Lead registrations, submissions, notifications, and amendments while coordinating with R&D, Quality, Manufacturing, and Commercial teams to obtain technical documentation and certifications. Monitor emerging regulations and industry trends to drive required actions and maintain ongoing compliance with global standards. Manage multiple regulatory projects simultaneously, establish priorities, identify risks, and ensure deliverables are completed within established timelines.
Required Qualifications
- Bachelor's degree (+/- 16 Years)
- Minimum 5 years Bachelor's degree in a scientific, engineering, regulatory, or related discipline
- 7+ years of Regulatory Affairs experience in a regulated healthcare industry
- Demonstrated experience supporting product launches and lifecycle management activities
- Knowledge of global medical device regulatory requirements and quality system regulations
- Strong project management, stakeholder management, and organizational skills
- Ability to manage multiple priorities and work effectively in a cross-functional environment
- Strong written and verbal communication skills with the ability to influence and collaborate across functions
- English Fluent
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