Our client is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Their disruptive technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems.
At the heart of this fast-growing company, the Regulatory Affairs Specialist will be responsible for developing and planning multiple regulatory affairs projects and activities.
We are looking for a self-starter who likes challenges requiring critical thinking and has keen problem-solving skills. In this role, your work will include activities such as;
- Develop and implement global regulatory strategies designed to:
- reduce product development cost/time
- achieve faster-than-average review times with regulatory bodies
- Review and approve protocols, reports, engineering drawings, procedures, labeling and other product development and manufacturing documentation to ensure compliance with regulatory requirements, consistency and accuracy.
- Provide direction and guidance to project teams to execute tactical regulatory affairs projects and/or initiatives. Includes preparation and oversight of larger documentation packages for submission to regulatory agencies. Track timelines and documents for inclusion in regulatory submissions. Interact with regulatory agencies as part of submission review and on-site audit support.
- Identify and evaluate regulatory affairs process improvement and/or course correction/course alignment opportunities to accelerate route to market access in collaboration with key stakeholders.
- Develop strategies and contingency plans for projects, including those that are most complex and challenging
- Anticipate and advise on future regulatory trends and direction, and recommend preemptive approaches for company regulatory compliance
- Key member in RA committee (e.g., AdvaMed, standards/committee) and provide input in the development of standards/regulations that affect the Medical Device industry
The ideal person for this job should have a Bachelors degree, and a scientific discipline is required. You should have a 5-7 years previous related experience, expert knowledge and understanding of global regulations relevant to Class III and/or Class III medical devices.