Associate Director, Regulatory Affairs - Medical Device

Novartis Pharmaceuticals Fort Worth , TX 76102

Posted 3 months ago

Job Description:

This role will support our Dry Eye and Ocular Health portfolio. The purpose of this position is to develop and implement global regulatory strategies to secure global market access for the assigned Franchise portfolio, in line with business objectives, and in coordination with key internal and external stakeholders.

  • Prepare and submit regulatory applications and filings including 510(K), CE Mark Technical Files while adhering to applicable quality standards, policies and procedures.

  • Provide regulatory leadership on project teams while leading development of medical device regulatory strategy and operations.

  • Sets mid-range objectives for assigned projects in Franchise, and sets near term objectives for Alliances and BD regulatory support.

  • Determines and pursues courses of action necessary to meet the organization's objectives and schedules.

  • Directs and coordinates activities concerned with research and development of projects.

  • Supports post marketing activities including adverse event reporting and product removal/recalls.

  • Regulatory subject master expert for Design Control activities including Design and Development planning, Design Input, Risk Management/ Risk Analysis, Design Output, Design Verification and Validation and Design Transfer.

  • Extensive knowledge of FDA's Quality System Regulations, GMP, ISO Regulations/Standards, and MDD/ MDR.

  • Provides Regulatory Affairs support for the assigned Franchise to the Therapeutic Unit Head and to Business Development and Alliances.

  • Creates, obtains and maintains alignment on Franchise global regulatory strategy in close collaboration with Regulatory Management.

  • Leads and coordinates all regulatory aspects of Development, Alliances and Business Development activities for the Franchise.

  • Develops and maintains effective relationships with regulatory authority staff at management level, and with key outside specialists in the area that Alcon uses as experts for regulatory dossiers and agency meetings.

  • Aligns strategic guidance across the project teams in the assigned portfolio.

  • Runs an effective and efficient regulatory sub-team, a matrix team that includes all functions needed to execute the accountabilities of the member.

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Associate Director, Regulatory Affairs - Medical Device

Novartis Pharmaceuticals