Posted in Other 4 days ago.
Regulatory Affairs Specialist I
Change people's lives and love what you do! Cochlear is the most recognized brand in hearing health care.
Human needs have always been our inspiration, ever since Professor Graeme Clark set out to create the first multi-channel cochlear implant because he saw his father struggle with hearing loss. We always start with people in mind - thinking about their needs.
For this reason, our products, services and support will continue to evolve and improve. We are by our customers' side through the entire hearing journey, so they can experience a life full of hearing. 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 and working in an organization where they can be part of bringing the mission to life each day.
About the role
In order to help Cochlear continue to grow and service our customers, we are recruiting for a Regulatory Affairs Specialist I in our Americas head office based in Lone Tree, CO.
To be successful in this role you'll be able to help bring innovative products and services to our customers. You'll work collaboratively with colleagues in regulatory affairs, quality, clinical affairs, marketing and operations to ensure that Cochlear is compliant with pre-market and post-market regulatory requirements for all medical devices. This individual contributor role is responsible for assembling documents and preparing electronic submission packages for applications to FDA and Health Canada.
To add value to Cochlear in this role you'll be able to meet and demonstrate the following knowledge, skills and abilities in your application and at interview:
Physical & Mental Demands
The physical and mental demands described below are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the individual is regularly required to be in a stationary (seated/standing) position; utilize business technology for work product delivery, communicate orally and in writing with others internal or external to the organization, utilize problem solving/critical thinking skills to discern and convey information. Specific vision abilities required by this job include ability to adjust focus.
While performing the duties of this job, the individual is regularly required to utilize comprehension, critical thinking, communication, problem solving, organization reasoning, relating to others and discernment of items such as product specifications, procedures and processes to customers (whether internal or external). Organization of information is also required.
The work environment is an office environment.
In addition to the opportunity to develop your knowledge and grow professionally, we offer competitive wages and benefits. The Target Hourly Rate for this role is $27.00/hour - $29.00/hour as well as a bonus 4% of base salary.
The overall benefit program includes medical, dental, vision, life and disability, pet insurance, 401K Matching, PTO (vacation, holidays, floating holidays, sick and volunteer time off), tuition reimbursement, transportation supplementation, maternity and paternity leave, and wellness programs.
Apply now by completing your application form online. Applicants must meet the job specific application criteria to be considered. Visit our careers site at www.cochlear.us/careers to learn more.
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 303-264-2549.