About TeraRecon | Incredible Things Happen

Sr. Regulatory Affairs Specialist

Location: USA - Durham(Research Triangle Park), NC
Company Order Number: 604
# of openings: 1

Description

About the Company

TeraRecon is a leader in advanced visualization and artificial intelligence solutions. Our flagship product, Intuition, is the market share leader for radiology and cardiology advanced visualization. Our AI division was awarded the best new radiology vendor for 2018 and nominated for best new software in 2019 by readers of industry news leader, AuntMinnie. Further, we were recently named the 2020 KLAS Category Leader for Advanced Visualization. We are committed to redefining advanced visualization by leveraging machine learning and improving radiology workflows through personalized automation that increases efficiency. TeraRecon is a privately-held global company with its world headquarters in Durham, NC, and major offices in Tokyo, Japan; Frankfurt, Germany; Fremont, CA and Acton, MA. While our employees are located across the world, we work as one company, functionally-aligned, and goal-driven. TeraRecon’s transparency and collaborative work environment foster an energetic and inviting culture.

 

About the Position

We are seeking for a Senior Regulatory Affairs Specialist to join our team.

 

The position is a based in our Durham, NC headquarters.

 

Responsibilities:

  • Develop regulatory submission strategies for new and existing software medical devices, and manage to completion.  This includes US, Canada, EU, Brazil, Australia, and other international territories that require registration. 
  • Provide guidance as needed to key stakeholders as submission deliverables are developed.
  • Review deliverables prior to inclusion in regulatory submissions.
  • Compile and submit regulatory filings to regulatory authorities and country representatives.
  • Serve as point of contact for regulatory agency requests for additional information.
  • Proactively review global regulatory requirements/changes.  Conduct gap analysis and effectively communicate requirements/changes to key stake holders.
  • Review product and process changes and determine impact to regulatory filings, and if regulatory agency notification is required.
  • Review and approve labeling, including but not limited to user manuals and marketing literature.
  • Participate in post-market surveillance activities.
  • Participate in internal audit program and external agency QARA audits.
  • Understand and practice requirements of ISO 13485 (including MDSAP), EU MDR, TeraRecon BMS Manual, Process Flows and Work Instructions.

 

 

Qualifications:

  • 7+ years of developing global regulatory submissions for medical device industry
  • Experience and knowledge of product and process regulatory compliance

 

 

Education:

  • BA/BS degree, MBA preferred, or equivalent job-related experience

 

 

 

Salary:  Depending on qualifications and experience.

Benefits: Medical, Dental, Vision, Life Insurance, LTD, STD, Section 125, and 401K

 

TeraRecon is an equal opportunity employer and a Federal subcontractor. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or veteran status.  For more information, please refer to the “ EEO is the Law ” poster. 





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