What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at ACE Partners?
Senior Regulatory Affairs Specialist – Medical Devices
About the Role
We are seeking a Senior Regulatory Affairs Specialist to support global regulatory activities for medical devices. This role partners with cross-functional teams to develop regulatory strategies, prepare submissions, and ensure products remain compliant throughout their lifecycle.
Responsibilities
- Develop and execute regulatory strategies for medical devices.
- Prepare and support global regulatory submissions and product registrations.
- Provide regulatory guidance for product changes, labeling, and lifecycle management.
- Collaborate with Quality, Engineering, Manufacturing, and R&D teams.
- Maintain regulatory documentation and support audits and compliance activities.
- Monitor regulatory changes and recommend actions as needed.
Requirements
- Bachelor's degree in a technical or scientific discipline.
- 5 years of regulatory affairs experience in the medical device industry.
- Knowledge of FDA, MDR, ISO 13485, and global medical device regulations.
- Strong communication, organization, and problem-solving skills.
- RAC certification is a plus.
If you're passionate about bringing compliant, high-quality medical devices to market, we'd love to hear from you.
Salary : $100,000 - $130,000