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FDA Regulatory Compliance Specialist
Milford, MA

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Must have a sense of urgency in meeting the demands of a fast-paced working environment. Must have the ability to quickly adapt to change, multitask, and have clear written and verbal communication skills to insure timely and effective correspondence with our other offices.

Responsibilities:

  • Manage line of FDA regulated products: Consumer medical devices (hot/cold packs, pregnancy test kits, drug test kits), OTC drugs (ointments and creams), Cosmetics, Food and Candy.
  • Maintain current knowledge of the developments and changes to applicable laws, regulations, monographs, guidelines and industry standards; obtain and distribute updated information, timely.
  • Interpret regulatory rules or rule changes and ensure that such are communicated through company procedures, training and communication with all involved, timely.
  • Identifying, researching and gathering relevant information from a variety of sources for regulatory, safety and marketing of product line mentioned.
  • Analyzing and evaluating data, procedures, interrelated processes and other information.
  • Formulating summary of research to QA department and other teams, timely.
  • Label reviews.
  • Work with 3rd party testing labels on product and labeling review.
  • Strong critical thinking and problem-solving skills. Ability to identify errors and provide corrective action. Ability to work with others in a team environment.
  • Responsible to know, understand and ensure FDA requirements/compliance for OTC Drugs, Medical Devices, Cosmetics and Food.
  • Work with and understand Ladder plans for inventory planning.
  • Work with and understand landing cost calculations.
  • Performs other functions as assigned and required.

Experience and Proficiencies required:

– Have or become FSVP Certified

– 2+ FDA Regulatory and Import Experience

– Certified Customs Classification Specialist (CCS), helpful.

– Exceptional written, communication and organizational skills – with proficiency in Microsoft Word, Power Point.

– Exceptional interpersonal, and collaborative skills, accepts constructive direction. Understands big picture goals.

– Strong analytical skills. Takes a quantitative approach to assignments.

– Task and detail focused. Executes with a plan (time and action). Strong sense of urgency.

– Problem solver, decisive. Can rationalize for best end result. Risk vs reward.

– Proven analytical skills

– Ability to multi-task and excellent attention to detail

– Knowledge of inventory management systems and procedures



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