Regulatory Affairs Specialist

US-WI-Madison
Req No.
2017-2016
Category
Quality Assurance & Regulatory Affairs
Type
Regular Full-Time

Summary of Major Responsibilities

The Regulatory Affairs Specialist writes, files, and obtains approvals for domestic and international regulatory submissions. The Regulatory Affairs Specialist defines the regulatory strategy for assigned projects, including new product development, product changes, and manufacturing improvement initiatives. Assist in creating, developing, and implementing global regulatory affairs procedures and educating others on global regulatory expectations and requirements.

Essential Duties and Responsibilities

  • Responsible for preparation and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution approvals and/or clearances
  • Determine and document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with project teams and regulatory management as needed.
  • Control and maintain regulatory records.
  • Represent Regulatory Affairs on various project teams by attending team meetings and providing the required plans, procedures and regulatory decisions.  Confer with other departments about the regulatory requirements of new product designs and/or changes to existing designs.  Review and approve new documents and product changes for compliance, and to determine if a new premarket application is required. 
  • Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry.
  • Reviews and approves product labeling and marketing material. Initiates new package inserts and other required product labeling.
  • Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations and policies applying to medical devices including, PMAs, 510(k)s, labeling and promotional materials,  global registration, and technical writing.

Qualifications

  • 4+ years relevant pharmaceutical/device regulatory experience
  • Bachelor’s degree in science or health related discipline
  • Strong technical writing skills
  • Effective communicator; able to convey messages in a logical and concise manner. Consistently reinforces regulatory expectations and requirements.
  • Exceptional attention to detail with strong organizational skills.
  • Independent self-starter; manages time effectively and completes tasks on-time with minimal supervision. Flexible and able to self-manage multiple priorities.
  • Able to work effectively in multinational/multicultural environments.
  • Adapts readily to changes in workload, staffing, and scheduling.
  • Complies with management direction. Seeks assistance from supervisor in identifying and reporting problems or concerns relating to job functions.
  • Conducts self in a professional manner with coworkers, management, customers, and others. Models the corporate values.
  • Has experience reviewing and approving product advertising and creating product labeling.
  • Has experience with adverse event reporting and is familiar with post-market surveillance and vigilance requirements.
  • Has experience with medical device and/or IVD regulations

Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. The Company’s affirmative action program is available to any applicant or employee for inspection upon request.

 

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