Oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of more complex products/programs.
Develop and manage parts of comprehensive global regulatory submissions and registration plans.
Interface with external management.
Build effective and enduring external relationships and apply effective stakeholder management practices.
Contribute to audits by supporting preparation, execution and follow up.
Lead the organization to adapt to the evolving regulatory environment and requirements.
Proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals.

Bachelor's / Master degree in Life Science, Data Science or related subject or equivalent experience.
3-5 years experience with PhD degree, 5-7 with Masters degree, and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
Experience with CLIA Regulations.
Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
Knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.
Demonstrated ability to manage more complex work and/or parts of global projects.

A discretionary annual bonus may be available based on individual and Company performance.
Health insurance
Retirement plans

Regulatory Affairs Manager

Key skills