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Regulatory Affairs Specialist II

Apply now Job no: 609584
Work type: Permanent
Location: Centennial
Categories: Quality & Regulatory, North America, Individual Contributor

Job Title:  Regulatory Affairs Specialist II    

Change people’s lives and love what you do!  Cochlear develops world-leading medical devices that help people hear. As the top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives.

About the role:

In order to help Cochlear continue to provide the highest quality of products on the market, we are recruiting for a Regulatory Affairs Specialist II in our Americas’ office based in Centennial, CO.

In this role, you will work closely with Cochlear teams as well as with the FDA and Health Canada, ensuring compliance with regulatory bodies. By working collaboratively with Clinical, Regulatory, Research & Development, Quality, and Marketing teams, you'll make certain all submissions lead to timely approvals, clinical evidence satisfies all regulatory bodies’ standards, and marketing materials support product claims. You'll know you've been successful in this role when you’ve helped design, document, and implement improved regulatory processes.

Key Responsibilities

  • Assemble documents, assist in the preparation and creation of regulatory submissions to the FDA and Health Canada (e.g., PMAs, supplements, 510(k)s, IDEs). Summarize technical information for submission to regulatory agencies. As requested, facilitate communication with FDA and Health Canada during ongoing review of submissions.
  • Assist in the maintenance of all files for PMA’s, 510(k)’s, correspondence with regulatory agencies, etc.
  • Assist in the review of sales and marketing literature and product labeling for approved product claims.
  • Help implement improved regulatory processes (e.g., electronic submissions, automation of routine reports, regulatory files and submission tracking, etc.)
  • Complete study monitoring visits and file applicable reports in a timely manner.

Key Requirements

To add value to Cochlear in this role you'll be able to demonstrate the following skills and experience in your application and at interview:

Key Incumbent Requirements: Minimum

  • Bachelor’s degree in Health sciences, or equivalent work experience
  • 1-3 years of regulatory experience in a medical device or pharmaceutical company
  • Strong written and oral communication skills
  • Ability to demonstrate strong analytical skills
  • Must be computer literate, with experience preferred in Microsoft Office suite

Key Incumbent Requirements: Ideal

  • RAPS Certification
  • Knowledge of US and Canadian regulations
  • Technical writing skills

Working at Cochlear Americas:

  • Work with dedicated and passionate colleagues to help more people hear
  • Highly collaborative global team environment
  • Opportunities for growth and development
  • Competitive salary and bonus
  • Comprehensive benefits including medical, dental, vision, life insurance, retirement plans, paid holidays/vacation, tuition reimbursement, and extended Paternity Leave.
  • State of the art facility with great work/life balance conveniences (onsite gym, wellness programs, dry cleaning services, company-sponsored monthly food truck and more!)

Cochlear Globally:

Cochlear pioneered and is the global leader in the research and development, manufacture and marketing of implantable hearing solutions. Cochlear’s global headquarters is located in Sydney, Australia where we design and manufacture the leading cochlear implant devices in the world. A success story in the commercialization of R&D, Cochlear has more than 60% share of the global market, employs more than 3,500 people worldwide, operates directly in over 20 countries and sells in over 100 countries. Over 550,000 people across more than 100 countries now experience hearing as a recipient of a Cochlear hearing solution.

As a world-leader in innovative medical devices, Cochlear encourages continuous learning for employees. Visit www.cochlear.com/careers for more information.

Cochlear Americas is an Equal Opportunity, Affirmative Action Employer and provides equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, marital status, veteran status, or any other characteristic protected by federal, state or local lawIn addition, Cochlear will provide reasonable accommodations for qualified individuals with disabilities.  If you require accommodation with completing the online application, please contact us via web or phone at 303-264-2349.

Advertised: Mountain Daylight Time
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