Regulatory Affairs Lead
7 dni temu
Solventum is a leader in the healthcare industry, dedicated to creating innovative solutions that improve lives. As a Senior Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with regulatory requirements across the globe.
Job DescriptionIn this position, you will be responsible for leading cross-functional teams and overseeing product line submissions and registrations worldwide. You will work closely with the international regulatory affairs group to ensure products meet global regulatory standards.
The ideal candidate will possess a strong understanding of regulatory affairs and have experience authoring submissions and technical documentation for US, Canada, EU, and supporting EMEA, APAC, and LATAM regions.
You will also have the opportunity to support labeling and registration changes due to company spin-offs.
Key Responsibilities:
- Conducting global regulatory change assessments and coordinating associated activities for assigned products.
- Demonstrating operational and strategic mindset that is results-oriented with a strong bias towards executing with speed, agility, and quality in addition to excellent organizational, prioritization, oral and written communication skills.
- Providing regulatory review of technical reports and documents.
- Providing contributions for development and implementation of regulatory processes.
- Documenting and managing metrics.
- Leading regulatory filings as needed for continuity projects (directly for EU/USA, and supporting ROW).
- Supporting risk management activities, vigilance reporting activities, and other quality related initiatives with minimal oversight.
To succeed in this role, you will need:
- Bachelor's Degree or higher from an accredited university in a scientific discipline such as Biology, Chemistry, Biomedical Engineering, or Physics.
- 7-10 years in regulatory affairs in the medical device industry.
- Direct experience authoring submissions/technical documentation for US, Canada, EU, and supporting EMEA, APAC, and LATAM regions.
- Direct experience authoring regulatory strategies and regulatory change assessments.
- Expert technical writing and verbal skills in the English language.
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