Regulatory Affairs Specialist (Remote)
Madison, WI  / Sunnyvale, CA 
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Posted 1 day 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 Specialist is responsible for pre-market and post-market regulatory affairs to support Accuray's product strategy in the Americas Region. The Specialist opens market access for Accuray's industry leading radiation therapy technology by producing regulatory submissions for the USA, Canada, and Brazil and working through representatives throughout North and South America. The Specialist also supports regulatory reporting activities for events and recalls, such as US Medical Device Reports (MDR) and Correction & Removal Reporting. In addition, this position will engage in regulatory intelligence for the Americas Region to identify developing standards and regulations and align company practices. This role will also contribute to the continuous improvement of the regulatory affairs function through projects and support.

Essential Duties and Responsibilities:
  • Develop and prosecute pre-market submissions (510k) to expand market access for Accuray's products in USA, Canada, and Americas.

  • Execute facility submission plan for Americas region to maintain access for Accuray's products.

  • Assist distributors to support business and product registrations in indirect markets.

  • Prepare materials to enable Medical Device Reports, Vigilance, Adverse Events, Recall, decision making and reporting.

  • Represent recall activities, progress, and closure to regulatory agencies.

  • Manage product controls for quoting, ordering, and shipping medical devices for the Americas.

  • Prepare documentation and reports interpreting and implementing federal, state, and/or international regulations for the company, customers, governmental regulatory agencies, etc.

  • Create and sustain systematic regulatory intelligence to translate intelligence into process or product requirements.

  • Support document legalization activities.

  • Assist with FDA facility inspections, Notified Body Audits and other governmental inspections.

  • Ensure documents and records are filed and maintained to demonstrate compliance to regulatory requirements and preserve organizational knowledge.

  • Assist as needed in other activities within the ARQ Department.

Qualifications:

a. Required:

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

  • Minimum of 3 years of experience in regulatory affairs in a medical device development and manufacturing environment.

  • Demonstrated knowledge of US FDA regulations, Canadian Medical Device Regulations, and various quality system standards/regulations/laws, including but not limited to 21 CFR 820 and ISO 13485 applicable to medical device product registration, recall, and medical device safety reporting.

  • Excellent verbal and written communication skills.

  • Excellent organizational skills.

  • Strong interpersonal skills and cross-cultural competency to enable building of trusting relationships across functions and geographies.

  • Ability to travel domestically up to 10% of time.

#LI-ML1

#Remote

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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