Regulatory Affairs – Medical Device

14 Jul, 2020

Jobs

Regulatory Affairs – Medical Device

Anutra Medical
Raleigh, NC

Job Function:  Regulatory Affairs

Anutra Medical is transforming the way in which local anesthetics are buffered and delivered to patients. With the Anutra Dispenser, Cassette and Syringe, practitioners can increase productivity and enhance patient experience.

Job Summary  

  • Provide support for MDSAP ISO13485:2016 certification.  Work flexibly to provide broad operational support to ensure the delivery of product team and business objectives.

Major Accountabilities

  • Support the Vice President of Technical Operations for the delivery of timely approvals and product information in keeping with the needs identified for MDSAP ISO 13485:2016 certification with certifying body
  • Assist with MDSAP ISO 13485:2016 Stage 1 and Stage 2 audits with certifying body
  • Liaise proactively with the functions and participate as a member of a cross-functional team providing regulatory advice
  • Identify potential regulatory risks to the operational plan and propose options to mitigate risks
  • Provide regulatory expertise on regulatory documents, certifying body briefing documents and response documents
  • Ensure that appropriate, up-to-date records are maintained for compliance

Education and Qualification

  • Bachelor degree required
  • 2+ years medical device experience with knowledge of assigned regional regulatory procedures and legislation
  • Regulatory Affairs Certification (RAC)

 Competencies

  • Build effective partnerships – identifies opportunities and takes actions to build effective relationships within team and with other areas
  • Influencing skills – through well thought through rationale and effective communication skills, able to influence key decisions
  • Flexibility and adaptability – Decides what to do based on the situation. Changes behavior or approach to fit the situation or the person.  Works effectively in ambiguous situations.
  • Communication skills – knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
  • Results focused – ability to overcome obstacles and achieve key outcomes
  • Analytical – logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
  • Organizational Skills
  • Integrity – overriding commitment to integrity and high standards in self and other

Learn more here

Job posted: 2020-07-14