Director Global Regulatory Affairs

02 Oct, 2020


Director Global Regulatory Affairs

AgNovos Healthcare
Rockville, MD

This role will be a key member of the Finance team with primary focus on producing financial information and providing actionable financial analysis and decision support to management. Responsible for ensuring timely and accurate financial reporting, compliance with policies, and maintaining and enhancing a strong control environment. In addition, the Staff Accountant will be responsible for accounting activities including the monthly close, account reconciliations, and supporting the year-end audit.

Summary of position:

This person will be a critical member of the AgNovos team, responsible for helping drive the development and execution of AgNovos’ global regulatory strategy, and primarily responsible for all operational aspects of regulatory submissions and compliance. She or he will participate broadly across the organization to ensure excellent communication, collaboration and coordination, particularly with the clinical, R&D, quality, operations and legal teams.

Essential Duties and Responsibilities:

  • Maintain currency on medical device regulations in key jurisdictions
  • Ensure compliance with applicable rules and regulations, across all jurisdictions
  • Administer core regulatory processes including claims review, label development and literature reviews
  • Manage all regulatory submissions/reporting activities
  • Maintain regulatory documents/records including submissions, regulatory correspondence, product technical and device master files, and registration dossiers
  • Analyze and develop global regulatory pathways and timelines, working with internal and external stakeholders
  • Support development of global regulatory strategy to obtain rapid approvals with favorable indications for AgNovos’ products
  • 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

Direct reports and other key relationships:

  • Direct reports: N/A
  • Other Key relationships: R&D, Clinical, Quality, Operations

Skills and Qualifications:

  • 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
  • Familiarity with device regulations for the U.S., E.U., Canada, and Japan
  • 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 within AgNovos and with external vendors
  • 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

About AgNovos Healthcare:

AgNovos Healthcare is a privately held medical device company focused on bone health, a crucial quality-of-life issue facing the aging population. Founded by renowned orthopedic surgeon Dr. James Howe, AgNovos is headquartered in Rockville, MD. Through scientific rigor and the compassion born of Dr. Howe’s decades of working with patients, AgNovos Healthcare aims to reduce the devastating personal and societal costs of diseases like osteoporosis. The company is developing innovative treatments that have the potential to alter the landscape of bone health. By bringing new technology to market, the company strives to help patients maintain their mobility and independence.

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Job posted: 2020-10-02