Job Title: Regulatory Affairs Specialist I
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 bring new products to market and support cochlear implant recipients we are recruiting for a Regulatory Affairs Specialist I in our Americas head office based in Centennial, CO.
To be successful in this role, you’ll be able to assemble and prepare paper and electronic submissions for regulators and participate in the internal content review board. You’ll work collaboratively with colleagues in the Clinical, Marketing, and Operations departments to help bring new products to market and satisfy the requirements of our regulatory bodies.
In this role you'll have the opportunity to make a significant contribution to Cochlear's successful history of innovation by applying your knowledge of the health sciences and strong communication skills. You'll know you've been successful in this role when you've helped ensure compliance with regulatory requirements while establishing and growing your career in Regulatory Affairs.
- Assemble and prepare submissions to regulators
- Coordinate post-approval reporting obligations
- Participate in Content Review Board
- Maintain licenses and registrations
- Provide operational and administrative support
- Provide assistance and support field actions, including acting as the recall coordinator
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:
- Bachelor’s degree in Health Sciences or equivalent work experience
- Strong written and verbal communication skills
- Computer literate with Microsoft Office knowledge (Word, PowerPoint and Excel)
- The ideal candidate will have prior experience in life sciences and within a regulated industry (Medical Devices, Pharmaceuticals, etc.)
Working at Cochlear Americas:
- Work with dedicated and passionate colleagues to help more people hear
- Diverse culture
- Highly collaborative team environment
- Opportunities for growth and development
- Competitive salary, benefits and bonus
- State of the art facility with great work/life balance conveniences (daily on-site coffee barista, onsite gym, dry cleaning services and more)
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 a 60% share of the global market, employs more than 2,500 people worldwide, operates directly in over 20 countries and sells in over 100 countries. Over 250,000 people across more than 100 countries now experience hearing as a recipient of a Cochlear hearing solution. Cochlear can offer:
- The Work - A high impact job supporting world leading technology
- The Organization – A global leader in active implantable medical device hearing technology
- The Opportunity – To make a difference to the quality of people’s lives and grow your career
As a world-leader in innovative medical devices, Cochlear encourages continuous learning for employees. Visit www.cochlear.com/careers for more information.
Apply now by completing your application form online. Applicants must meet the job specific application criteria to be considered.
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 law. In 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.