Regulatory Affairs Specialist

4 weeks ago


Bethlehem, Pennsylvania, United States Tyber Medical LLC Full time

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.
Required Skills and Qualifications:
  • 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.
Benefits:
  • 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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