Regulatory Affairs Specialist
4 weeks ago
Regulatory Affairs Specialist at Tyber Medical LLC
Job Overview:We are seeking a highly skilled Regulatory Affairs Specialist to join our team. In this role, you will play a key part in ensuring the success of our clinical trials and post-market surveillance activities. Your primary focus will be on coordinating and supporting clinical research to ensure product safety, efficacy, and regulatory compliance.
Key Responsibilities:- Assist in the planning and implementation of clinical research protocols.
- Coordinate with clinical sites to facilitate subject recruitment, retention strategies, and support overall study enrollment goals.
- Support day-to-day operations of assigned studies, ensuring adherence to protocol requirements, and timelines.
- Act as a contact for site staff and ensure clear communication regarding study updates.
- Bachelor's degree in life sciences, healthcare, or a related field.
- 1-2 years of experience in clinical research/clinical affairs, within the medical device, healthcare industry, or CRO setting.
- Knowledge of FDA, EU MDR, ICH-GCP, ISO 14155, IRB, and ISO 13485 regulations.
- Proficient in Electronic Data Capture (EDC) systems and clinical trial management software.
- Excellent organizational skills with the ability to manage multiple tasks and prioritize effectively.
- Strong written and verbal communication skills, with attention to detail in documentation.
- Ability to work independently and as part of a cross-functional team in a fast-paced environment.
- A competitive salary range of $60,000 - $80,000 per year.
- A comprehensive benefits package, including medical, dental, and vision insurance.
- A 401(k) retirement plan with company match.
- Generous paid time off and holidays.
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