Senior Regulatory Affairs Specialist
1 week ago
Vision Achievement
We are seeking a highly experienced and skilled Senior Regulatory Affairs Specialist to join our team at Vision Achievement. This is an exciting opportunity for professionals who have a passion for patient safety and population health improvement.
About the Role:
As a Senior Regulatory Affairs Specialist, you will be responsible for planning and delivering Life Science consulting engagements related to quality/regulatory affairs infrastructure, appropriate to the level of risk in a target product. You will work closely with clients to understand their needs and develop effective solutions that meet regulatory requirements.
Key Responsibilities:
- Design and implement quality systems plans and procedures aligned with regulatory requirements.
- Lead audits and assessments to ensure compliance with regulatory standards.
- Develop and submit regulatory submissions, including 510(k) applications.
- Maintain expertise in relevant regulations, such as 21 CFR 800-899 and ISO 13485.
Requirements:
- Bachelor's degree in Engineering, Science, or a Life Sciences-related field.
- Minimum 8 years of experience in RA/QA roles, preferably in medical devices or pharmaceuticals.
- Proven track record of designing and implementing successful quality systems and regulatory strategies.
Compensation:
This role offers a competitive salary range of $120,000 - $180,000 per year, depending on experience. We also offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
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