Senior Regulatory Specialist
2 weeks ago
CorDx is a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. We deliver rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. As an Associate Director of Regulatory Affairs, you will play a key role in leading and managing the regulatory submissions for our medical device products.
This full-time position is based in San Diego, California, and we are offering a competitive salary of $165,000 - $185,000 per year, depending on experience. The ideal candidate will have a Bachelor's degree in Life Sciences, Engineering, or a related field; advanced degree preferred. A minimum of 7-10 years of experience in regulatory affairs within the medical device industry is required. The selected individual will be able to demonstrate strong leadership and project management skills, excellent communication and negotiation skills, and a detail-oriented approach to work.
The responsibilities of this role include preparing, reviewing, and submitting regulatory documents to FDA, managing and overseeing the regulatory submission process, ensuring that all products comply with applicable regulatory requirements, providing regulatory guidance to R&D team during product development life cycle, staying updated on changes in regulatory requirements, and conducting regulatory assessments for product changes.
We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.
**Key Responsibilities:**
- Prepare, review, and submit regulatory documents to FDA.
- Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals.
- Ensure that all products comply with applicable regulatory requirements, including FDA regulations and ISO standards.
- Provide regulatory guidance to R&D team during product development life cycle.
- Stay updated on changes in regulatory requirements and communicate potential impacts to the organization.
- Conduct regulatory assessments for product changes and provide recommendations for appropriate regulatory pathways.
- Collaborate with internal stakeholders and external partners to ensure alignment on regulatory strategies and project timelines.
- Represent the company in meetings with regulatory agencies and external partners as needed.
- Ensure proper documentation and maintenance of regulatory submissions and correspondence with regulatory agencies.
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