Regulatory Affairs Expert for Medical Device Manufacturing
7 days ago
Job Opportunity: Senior Regulatory Affairs Specialist in Thousand Oaks, CA
We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Thousand Oaks, CA. As a key member of our regulatory affairs department, you will be responsible for planning and coordinating medical device regulatory submissions across various international markets.
Salary: $125,100 per year, with potential for annual performance bonus and comprehensive benefits
Job Responsibilities:
- Independently plan and coordinate medical device regulatory submissions
- Provide regulatory strategy and assess the impact of changes on existing products
- Review and approve marketing communication materials while ensuring compliance with regulations
- Support external audits and maintain communication with regulatory authorities regarding submissions
- Create and update departmental standard operating procedures (SOPs)
Requirements:
- Bachelor's Degree in Engineering, Life Sciences, or a healthcare-related discipline
- 3-5 years of experience in medical devices regulatory submissions
- Proven experience with 510(k) submissions and international registration processes
- Strong organizational skills and ability to multi-task effectively
- Proficient in MS-Office Applications and knowledge of quality system requirements
Preferred Qualifications:
- Experience with FDA, Health Canada, and international regulatory agencies
- Advanced degree and/or Regulatory Affairs Certification (RAC)
- Strong communication skills with the ability to present information effectively
- Experience in supporting international registrations and knowledge of medical device regulations
- Ability to negotiate with regulatory agencies and solve regulatory issues
This is an exciting opportunity to work with a leading medical device company and contribute to the development of innovative products. If you have a strong background in regulatory affairs and a passion for ensuring compliance, we encourage you to apply.
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