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Regulatory Affairs Specialist

3 months ago

Poway, United States Astrix Full time

Our partner is known for their eclectic services within the healthcare industry. Our partner is holds priority in the quality of care among community members, throughout their therapy and products everyday. Their team is seeking a Regulatory Affairs Specialist, to contribute to their innovative culture at their site in San Diego, CA


Pay Rate: 36/hr-39/hr


Responsibilities:


  • Develop global regulatory strategies and identify necessary registration data.
  • Experience as a liaison and advisory to support, communicating registration needs and strategies.
  • Experience staying knowledgeable with current industry trends, and attend Global Regulatory Affairs in R&D meetings.
  • Plan, organize, and prepare registration packages according to local regulatory requirements.
  • Assist in preparing, coordinating agency meeting packages and strategies.
  • Evaluate manufacturing , labeling changes, and materials for regulatory products.


Requirements:


  • Master’s or Bachelor’s Degree preferred.
  • Holds 3-5 years experience in Regulatory Affairs, R&D or related fields.
  • Experience with software, 510(k), Q-sub, and MDR Technical Documentation preferred.
  • Ability to prioritize, multitask, and adapt to fast-paced environments.
  • Knowledgeable on scientific terms and business needs.
  • Good communication and negotiation skills.
  • Less than 5% travel required.