Regulatory Affairs Specialist with Engineering Expertise
1 week ago
We are seeking a highly skilled Regulatory Affairs Associate to join our team at Collabera.
This role will involve working closely with cross-functional teams to manage regulations and ensure compliance with government requirements.
Key Responsibilities- Manage regulations and work with cross-functional teams to ensure compliance
- Analyze and understand regulations before meetings with stakeholders
- Perform documentation work to identify gaps in processes or product design
- Filing necessary applications and handling government interactions pertaining to the regulation process
- Review and approval of engineering study protocols/reports and validation study protocols/reports
- Review and assessment of emerging regulations
- May require an advanced degree and 2-4 years of direct experience in the field
- Bachelor's degree in relevant field or equivalent experience
- Proven track record of managing regulations and ensuring compliance
- Excellent analytical, communication, and problem-solving skills
- Ability to work effectively in a fast-paced environment
- Knowledge of medical devices design controls and Agile PLM system
At Collabera, we offer a competitive salary range of $80,000 - $110,000 per year, depending on experience.
In addition to a competitive salary, we also offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
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