Senior Regulatory Professional
5 dni temu
Solventum is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. In this role, you will be responsible for ensuring compliance with regulatory requirements and making strategic decisions that drive business growth.
About the RoleThis is a leadership position that requires exceptional communication and problem-solving skills. The successful candidate will have a strong understanding of regulatory affairs and experience working with cross-functional teams.
The Ideal Candidate Will:
- Possess a Bachelor's Degree or higher from an accredited university in a scientific discipline such as Biology, Chemistry, Biomedical Engineering, or Physics.
- Have 7-10 years of experience in regulatory affairs in the medical device industry.
- Be able to author submissions/technical documentation for US, Canada, EU, and supporting EMEA, APAC, and LATAM regions.
- Be able to author regulatory strategies and regulatory change assessments.
- Have expert technical writing and verbal skills in the English language.
In this role, you will:
- Conduct global regulatory change assessments and coordinate associated activities for assigned products.
- Demonstrate 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.
- Provide regulatory review of technical reports and documents.
- Provide contributions for development and implementation of regulatory processes.
- Document and manage metrics.
- Lead regulatory filings as needed for continuity projects (directly for EU/USA, and supporting ROW).
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