Regulatory Director

Rockville, MD

Posted: 01/18/2019 Employment Type: Direct Placement Job Number: 11777023

Professional Qualities:
  • Great attitude
  • Works well in a team environment
  • Dependable and reliable
  • Very punctual, always arrive on time
  • Pleasant and diligent
Responsibilities and Duties:
  • Support development of global regulatory strategy to obtain rapid approvals with favorable indications for products
  • Ensure compliance with applicable rules and regulations, across the organization
  • Ensuring effective relationships with global regulatory bodies
  • Analyze and develop global regulatory pathways and timelines, working with internal and external stakeholders 
  • Administer core regulatory processes including claims review, label development and literature review
  • Execute optimal submission process and ensure continuous improvement
  • Maintain regulatory records, including submissions and correspondence with global regulatory bodies
  • Maintain internal regulatory documents and product registration files (such as technical files, device master files and global registration dossiers)
  • Manage regulatory reporting activities
  • Participate in key cross-functional activities, including clinical strategy development, product lifecycle management and marketing review
  • Design and implement processes for gathering global regulatory intelligence and raise awareness within the organization of current trends in regulatory development and enforcement
  • BA/MS in life science or engineering discipline preferred but not required; advanced degree an advantage; RAC certification a plus
  • 3+ years' regulatory affairs experience in the medical device, pharmaceutical, biotech or relevant industry; global experience/exposure preferred
  • Familiar with device regulations for the U.S. And E.U.
  • Familiarity with key stages of medical device, pharmaceutical or biotech development, manufacturing, process validation, analytical operations, compliance and documentation. Experience with IDE, PMA preferred
  • Solid experience in regulatory operations, including: formatting, publishing, assembling and submitting (both electronic and paper submission) and records management
  • Strong combination of strategic thinking and tactical day-to-day problem-solving; ability to act decisively and skilled in cross-functional communication; ability to provide strategic and operational guidance across all levels
  • Excellent written and verbal communication, negotiation/persuasion, presentation and interpersonal skills
  • Ability to provide top-quality, proactive, accurate, timely and effective support in a fast-paced environment; ability to work individually and collaboratively with a variety of individuals
  • Strong analytical, project planning, risk identification and problem-solving skills
  • Detailed oriented
  • Working knowledge of personal computer systems and office applications

Amanda Krape

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