ASSOCIATE REGULATORY AFFAIRS SPECIALIST

Descripción del puesto.
Careers that Change Lives We are a company inspiring the extraordinary, For more than 70 years, we have led the way with purpose-driven healthcare technology.
That history compels us to relentlessly pursue therapies that change lives.
The role is opened to continue our daily milestone in serving our patients & partners and give them the highest level of support & partnership which is aligned with our daily mission to alleviate pain, restore health, and extend life.
In this vital role you will be responsible of setting submission plan, driving accountability and operational excellence for execution in compliance with (COMPANY NAME) standards and national regulatory requirements for Portugal.
You will develop and maintain a broad set of collaborative relationships across the organization and with external stakeholders and partners that will allow you to successfully contribute to achieving organizational goals.
A Day in the Life • Being responsible for vigilance submissions and following up including posting marketing vigilance reports, Field actions and global complaints handling.
• Directs or performs planning, coordinating, and preparing of post marketing vigilance documents for regulatory submissions.
• Acting as point of contact with health authority vigilance department.
• Promoting, maintaining, and improving compliance with country regulatory requirements.
• Dossier reviewing and submitting responsibilities for new launches, lifecycle maintenance and posting marketing vigilance activities.
• Ensuring alignment of regulatory objectives with regional/ global regulatory objectives and commercial plans.
• Keeping abreast of regulatory procedures and changes affecting business and ensuring communication to relevant stakeholders, monitoring and improving tracking / control systems.
• Establishing effective communication and continuous follow-up with external agencies & distributors, ensuring compliance with company’s Standard Operating Procedure (SOPs) and working practice.
• Quality system control performing Internal and External audits.
• Onboarding responsible for the Quality Assurance and Regulatory Affairs (QA&RA) part.
Tender & Operating Unit support Must Haves • Bachelor’s degree, Pharmaceutical/Medical/ Science background.
• Minimum 2 years of related vigilance and regulatory experience.
• Experience with Portugal Medical Devices Vigilance and regulatory requirements.
• Organizational skills & regulatory project management skills.
• Strong communication skills both verbal and written.
• Excellent verbal and written English.
• Self-motivated, proactive, dynamic, organized, and decisive.
Nice to Haves • Previous experience in a Medical Devices multinational company.
• Completion of Portugal Medical Device Vigilance training program.
We Offer We offer a competitive salary and benefits package to all our employees.
• Flexible working environment • Annual Incentive Plan % depending on company results • Pension scheme and group discount on healthcare insurance • Training possibilities via Cornerstone/Harvard Manage Monitor/Skills Lab • Employee Assistance Program and Recognize! (Our global recognition program) Our commitment Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within (COMPANY NAME) and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute.
We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communities if we hope to have long-term sustainable impact.
Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of (COMPANY NAME) employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world.
About (COMPANY NAME) Bold thinking.
Bolder actions.
We are (COMPANY NAME).
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of + passionate people.
Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.
Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world.
In everything we do, we are engineering the extraordinary.
Your Answer Is this the position you were waiting for? Then please apply directly via the apply button! #LI-Hybrid