Regulatory Affairs Program Manager

8 - 10 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 09/22/17
Cleveland, OH
8 - 10 years experience
Biotech/Pharma
Salary depends on experience
Posted on 09/22/17

escription

Make a difference! Be inspired! Accuray helps cancer patients live longer, better lives.

Accuray Incorporated (Nasdaq: ARAY) invents, manufactures and supports a complete portfolio of radiation therapy and radiosurgery platforms for treating multiple forms of cancer. Our team works passionately to create a future without the fear, pain or human suffering of cancer. With over 800 systems installed worldwide, our leading edge technologies - the Cyberknife®, TomoTherapy® and Radixact™ Systems - put the emphasis on patient-focused care. Our offerings range from high-precision radiosurgery for early-stage and localized disease to 3D image-guided, intensity-modulated-radiation therapy for more advanced disease throughout the body.

The Regulatory Affairs Project Manager obtains medical device pre-market regulatory approvals to ensure global market access is realized for Accuray products and services.  Authors regulatory submission in the US, Canada, and Europe and works through third party entities in the rest of the world.  This position must be vigilant of developing standards and regulations and their impact on Accuray product clearances.  In addition, this position may contribute to post-market agency reporting activities, i.e. US Medical Device Reports (MDR) and Correction & Removal Reporting, and will be responsible for leading various projects that contribute to regulatory efficiency in the product development process.

 Responsibilities:

  • Prepare, submit, and manage regulatory clearance applications required for product market approvals in the US and Canada.
  • Prepare, submit, and manage European Design Dossier/Technical Files in compliance with the requirements of the Medical Device Directive and the Accuray Quality Management System.
  • Function as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams.
  • Assist research personnel, application specialist, risk management specialist, to ensure clinical research and clinical evaluation are performed in accordance with necessary regulatory requirements.
  • Participate as subject matter expert in internal and external quality system and design dossier audits.
  • Gather and prepare materials to enable Medical Device Reports, Vigilance, Adverse Events, Recall, etc. decision making processes.
  • Collate and prepare materials, reports, and follow-up actions with regulatory agencies regarding recall activity.
  • Co-ordinate international reporting with regional representatives.
  • May prepare documentation and reports after interpretation of federal, state, and/or international regulations for submission to other units of the company, customers, governmental regulatory agencies, etc.

Qualifications:

Required:

  • Bachelor's degree in business, engineering, or a physical science discipline.
  • Minimum of 7 years of experience in regulatory and/or quality assurance in a medical device development and manufacturing environment.
  • Solid working knowledge of the global regulations and standards applicable to medical device market clearance.
  • Proven track record clearing medical devices to market in the US, Canada, and Europe. 
  • Proficiency in working through third parties to obtain market clearance in other countries.
  • Excellent verbal and written communication skills; strong attention to detail.
  • Excellent organizational skills.
  • Strong interpersonal skills and cross-cultural competency to enable building of trusting relationships across functions and geographies.
  • Ability to travel domestically and internationally up to 10% of time.

Preferred:

  • Experience in project management.
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