Senior Regulatory Compliance Specialist

Celanese   •  

Las Colinas, TX

Industry: Manufacturing

  •  

5 - 7 years

Posted 40 days ago

Responsibilities:

This position was created to support the EM Medical Technologies team at their request.

This person will:

  • Serve as the SME for for EU regulations in medical/pharmaceutical/healthcare applications.
  • Lead Product Risk Management Reviews
  • Assist customers with regulatory submissions
  • Manage correspondence with regulatory agencies, especially in the EU.

Qualifications:

  • Strong understanding of EU regulatory framework for medical and pharmaceutical chemical manufacture.
  • Proficient in conducting and documenting regulatory product risk assessments.
  • Good understanding of GMP and quality principles as they apply to the medical and pharmaceutical product manufacture
  • Familiar with US and EU medical device and drug development process (MDD, MDR, 510K, IND, NDA, ANDA).
  • Familiar with MAF, DMF and eCTD format required.
  • Ability to interpret regulations and translate regulatory requirements into compliance strategies.
  • Ability to manage multiple projects in a fast paced environment.
  • Ability to effectively oversee projects outsourced to consultants/laboratories.

Required Years of Experience

  • Minimum 3 years regulatory/product stewardship experience in medical or pharmaceutical area.
  • 5 - 7 years preferred

Required Education

  • Bachelor of Science in Chemistry, Biological or Life Sciences (biochemistry, toxicology, etc)

2018-8880