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Principal Regulatory Affairs Specialist (remote position)

Apply now Job no: 614519
Work type: Permanent
Location: Oakland, California, Boston, Massachusetts, Lone Tree, Colorado, Newark, New Jersey, Philadelphia, Pennsylvania, San Diego, California
Categories: Quality & Regulatory, North America, Individual Contributor

Principal Regulatory Affairs Specialist (Remote position)

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

As Cochlear continues to grow and service our customers, we are recruiting for a Principal Regulatory Affairs Specialist in our Americas head office based in Lone Tree, CO. This role is remote for U.S. based applicants.

In alignment with our organizational principle of providing a safe work environment, employees of Cochlear are required to be fully vaccinated against COVID-19. The only allowable exceptions include qualifying medical and religious accommodation. Proof of your COVID-19 vaccination will be required prior to your start date.

To be successful in this role you’ll be able to contribute by providing regulatory guidance and expertise to bring innovative products to our customers, while ensuring Cochlear is compliant with premarket and post market regulatory requirements for all medical devices. You’ll work collaboratively with colleagues in the clinical, quality, and marketing departments to develop and execute strategies that will lead to timely device approvals. This subject matter expert role is responsible for using their expertise to develop and execute regulatory strategies for all product lines, including combination devices. 

Key Responsibilities

  • Develop and execute regulatory strategies for all product lines, including pre-submission meetings with regulators, for all product lines including device-led combination devices. Ensure company business goals are met by submitting regulatory applications within agreed timelines. 
  • Independently write executive summaries and compile documents for submissions of all types for FDA and Health Canada.  As the main contact for your written submissions, liaise with health authorities as needed to meet project goals.   This will include facilitating conference calls, documenting all written correspondence and running meetings with regulators. Ensure that meetings, submissions and follow up activities are of high quality, leading to timely approvals. 
  • Provide final documented assessment of any impacts of changes to devices, labeling, or manufacturing processes with an appropriate level of justification.  Serve as subject matter expert for global colleagues.
  • Represent Regulatory on cross functional teams and serve as subject matter expert and key contact.


Key Requirements

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:

  • 7+ years of experience
  • Demonstrated general knowledge and experience with Health Canada and Food and Drug Administration requirements.  Also requires specific knowledge of FDA requirements related to combination devices, including pre-clinical testing and analytical test method development and validation. 
  • Proven track record of management, writing, compilation, submission and maintenance of regulatory filings for Class II and/or Class III devices (FDA).  Must also have experience submitting combination devices for FDA approval.
  • Demonstrated analytical thinking skills to identify and resolve problems.
  • Some travel may be required

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. 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).  Influence, organization/classification of information and planning are also required. 


The work environment is an office environment, or home office environment and are representative of those an individual encounters while performing the essential functions of this job.

Schedule:

Generally typical business hours.  Some calls with global colleagues may fall outside standard business hours. 

In addition to the opportunity to develop your knowledge and grow professionally, we offer competitive wages and benefits.  The Target Salary Range is $115,000 – $140,000 based upon experience as well as a bonus of 15% of base salary.

The overall benefit program includes medical, dental, vision, life and disability, pet insurance, Employee Stock Purchase Plan, 401K Matching, PTO (vacation, holidays, floating holidays, sick and volunteer time off), tuition reimbursement, 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 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 303-264-2549.

Advertised: Mountain Daylight Time
Anticipated Application Closing:

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