Regulatory Affairs Program Manager
Madison, WI  / Solon, OH 
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Posted 5 days ago
Job Description

Give hope. Give health. Make your mark in the fight against cancer.

At Accuray, we make a direct and powerful impact on the lives of cancer patients every day - helping them live longer, better lives. But our commitment to innovation offers a truly unique opportunity: the chance to change the fight against cancer - helping to develop, introduce and support new treatment delivery systems and software that will give new hope and new health to cancer patients and cancer survivors around the world.

Accuray develops, manufactures and sells radiotherapy systems for alternative cancer treatments. Our radiation therapy for cancer makestreatment shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives.

Job Description

Summary:

The Regulatory Affairs Program Leaderrepresents Regulatory Affairs to new Product Development Teams and manages the global rollout of Accuray products and services. This role plans and manages medical device pre-market regulatory registrations and approvals to ensure global market access and implement the commercial marketing plan. The Regulatory Affairs Program Leadercollaborates with Region Regulatory Affairs organizations to generate global regulatory clearances.This position must be vigilant to monitor developing standards and regulationsand assess their impact on Accuray products and regulatory strategy. This position will be responsible for leading various projects to improve regulatory efficiency in the product development process.

Essential Duties and Responsibilities:

  • Develop and implement regulatory plans to achieve marketing objectives.

  • Represent Regulatory Affairs requirements to programs, and ensure the program produces the necessary evidence and deliverables to support the regulatory plan and commercial access.

  • Manage regulatory registration activities required for product global market entry.

  • Lead program activities to prepare documents such as Summary Technical Documentation in compliance with the regulatory requirements and the Accuray Quality Management System.

  • Function as a Regulatory Affairs subject matter expert onnew product introduction andengineering design control teams.

  • Provide Regulatory oversight over the product lifecycle including Design Changes and Adverting / Promotion reviews.

  • Assist research personnel, application specialists, risk management specialists, to ensure clinical research and clinical evaluations are performed in accordance with necessary regulatory requirements.

  • Participate as subject matter expert in internal and external quality system and design dossier audits.

  • 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:

a. Required:

  • Bachelor's degree in business, engineering, or a physical science discipline.

  • Minimum of 3 years of experiencein 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 registrations.

  • Proven track record registering medical devices.

  • 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.

b. Preferred or Desired:

  • Experience in project management.

  • Experience with capital equipment or medical device software.

#LI-ML1

To qualify for this position, candidates must be able to furnish proof that they are authorized to work in the country they are applying on a permanent basis without sponsorship.

EEO Statement

At Accuray, our commitment to patient-first outcomes drives an inclusive and collaborative work environment where the best ideas rise to the top - and everyone works to push them further. We value diversity in both the professional and personal backgrounds of our employees, as this variety adds rich energy to every team, every project and every work day. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin - including individuals with disabilities and veterans.


We are an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans and individuals with disabilities are encouraged to apply.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
3+ years
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