Regulatory Affairs Manager

Indianapolis, IN

About SonaCare Medical:

SonaCare Medical is a world leader in minimally invasive focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the following: Sonablate®, which has 510(K) clearance in the U.S. under a De Novo regulatory classification; Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 49 countries outside the U.S.; Sonatherm® laparoscopic HIFU surgical ablation system, which has 510(K) clearance in the U.S., has CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S.

Summary: 

The Regulatory Affairs Manager is responsible for preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities. This position will also prepare, monitor and communicate status of regulatory submissions and perform duties related to regulatory affairs post-market surveillance, recalls, and vigilance reporting.

Duties and Responsibilities:

  • Assist with development of regulatory strategies to support product development and operational objectives.
  • Provide regulatory feedback and guidance to the company throughout the development cycle. Independently prepare regulatory documents for product submissions or compliance actions. Collaborate with appropriate departments to ensure applicable materials are developed for new product market clearance, approval and continuance during product loife cycle; assemble materials and data required for timely completion of regulatory submissions: PMA 510(k), IDE and technical file for Notified Body.
  • Prepare regulatory non-filing justifications, as required.
  • Ensure that reporting requirements regarding new and modified devices requirements under European MDD and Canadian CMDCAS are met.
  • Review new and modified devices for fulfillment of FDA premarket obligations and identification of appropriate standards for electrical and mechanical safety with knowledge of FDA 510(k), FDA PMA, UL, MDD, and IEC requirements.
  • Maintain appropriate domestic and international registrations and product listings.
  • Compile all documentation needed for annual reporting and approval supplements.
  • Read and interpret regulations for new and current compliance procedures and regulatory enforcement trends/actions.
  • Provide assistance as needed with corporate regulatory compliance, such as HIPAA implementation.
  • Assist with the design, update, and adherence to standard operating procedures as they apply to specific performance areas.
  • All other duties, as assigned. 

Qualifications/Specifications:

  • Bachelors Degree – preferably in Life Sciences or Engineering disciplines
  • 5 years medical device industry experience in a regulatory affairs role, preferably with electro-mechanical software controlled devices
  • General understanding of ICH, Good Clinical Practices, FDA’s Quality System Regulation, ISO 13485, MDD, JPAL, CMDR, healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices.
  • Strong leadership and interpersonal communication skills.
  • Self-motivated with a proactive attitude and the ability to work independently.
  • Strong problem-solving and decision-making skills.
  • Strong written and oral communication skills.
  • Strong analytical and troubleshooting skills.
  • Strong organizational skills.
  • Team based department – open, honest communication is a must
  • Computer proficiency (MS Word, Excel, PowerPoint, Outlook, SharePoint programs).
  • Travel up to 20%, domestic and international.

 

Apply For This Position

HIFU company

Contact

10130 Perimeter Pkwy, Suite 250
      Charlotte, NC 28216

(888) 874-4384

info@SonaCareMedical.com

Mon - Fri: 9:00 - 5:00

Latest News

26 September 2017

Medicare recognizes HIFU prostate ablation as a device-intensive procedure driving new ASC payment going into effect on or after October 1, 2017 CHARLOTTE, N.C., Sept. 20, 2017 /PRNewswire/ -- SonaCare...

29 August 2017

CHARLOTTE, N.C., August 30, 2017 – SonaCare Medical, the leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, announces today the successful collaboration with BK Ultrasound, achieving compatibility...