Senior Manager of Regulatory Affairs

Organization
Asuragen, Inc.
Job Location
2150 Woodward St.
Suite 100
Austin, TX 78744
Benefits

We invest in your well being: health and dental coverage, stock options for every employee, wellness initiatives, disability coverage, 401(k) plan, professional development and more.

Job Description
  • Lead and manage the regulatory functions and projects by working with other members of the management team and cross functional development team to ensure regulatory filing are completed in a timely manner.
  • Recommend and develop the regulatory strategies related to FDA and international approvals of new product approval and strategic regulatory application functions.
  • Arrange, prepare for, and lead meetings with FDA and international agencies to establish regulatory requirements for novel in vitro diagnostic devices and accessories.
  • Develop overall timelines and plans by working with team members in research and development, QA, operations, and clinical affairs to ensure regulatory requirements are properly covered and implemented as part of product development plans.
  • Develop global regulatory strategies and update based upon regulatory changes.
  • Interact as the company representative with external contacts for clinical and regulatory functions, including FDA, state regulatory agencies, notified body representatives, IRB’s, CLIA, CAP and CROs, clinical advisors or clinical sites.
  • Prepare, file and manage regulatory submissions for class II and III 510(k), de novo 510(k), PMA medical devices, and Technical Files for CE marking of in vitro diagnostic (IVD) devices and Technical dossiers for international submissions with regulatory authorities.
  • Coordinate pre-approval inspections by FDA and international regulatory bodies
  • Communicate application progress to internal stakeholders.
  • Manage processes involved with maintaining annual licenses; registrations; listings and patent information.
  • Ensure compliance with product post-marketing approval requirements.
  • Review and approve advertising and promotional items to ensure regulatory compliance.
  • Review and approve publicly disseminated information to minimize regulatory exposure; review product claims; and preserve confidentiality of applicable product information.
  • Mentor, guide, and train direct reports and cross functional team members to increase regulatory affairs awareness. 
Requirements

 Minimum Education/Experience Requirements:

  • B.S./B.A. degree in Biology, Chemistry, bio-engineering or related science.
  • Minimum of 6 years’ experience with the medical device and or diagnostics industry.
  • Must have a minimum of 5 years regulatory experience in an IVD manufacturing environment with a proven track record of obtaining 510(k) or PMA approvals.
  • Knowledge and experience with novel molecular in vitro diagnostic assays and devices (and accessories to IVD’s) is a plus.
  • Demonstrated knowledge in the design and process of regulatory requirements data collections and analysis.
  • Working knowledge of current and evolving state, federal and international regulations and procedures relevant to the approval of in vitro diagnostic assays and medical devices.
  • Demonstrated ability find solutions to achieve company goals in effective and efficient manner.
About Our Organization

Asuragen is a global diagnostic products company delivering solutions that build knowledge and understanding of complex clinical questions. Asuragen’s application of its deep scientific heritage and molecular expertise delivers diagnostic products in oncology and genetics that provide the best answers with optimal workflows – so time can be spent delivering actionable insights, rather than searching for them. With innovative approaches to kit development and a broad range of molecular chemistries, Asuragen produces assays that ensure reproducible results. From discovery and development to regulatory support to global commercialization, we also provide a tailored approach that efficiently delivers custom and companion diagnostic products for our partners. Asuragen is located in Austin, Texas, which is consistently ranked in the top 10 of “best places to live” list of US cities. Asuragen offers a competitive salary, medical, dental, disability and life insurance, a 401(k) plan with company matching contributions, employee stock option plan, and a tuition reimbursement plan.