Clinical Quality and Compliance Manager at Cochlear in Lone Tree, Colorado

Job Description:

Change people's lives and love what you do! Cochlear is the most recognized brand in hearing health care.


Clinical Quality and Compliance Manager



Position Spotlight:

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  Bachelor's degree in healthcare, Life Sciences or similar degree field
  


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  5 years relevant clinical research experience
  


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  Must have knowledge of and experience in practical application of Good Clinical Practice principles and either pharmaceutical or medical device regulations including 21 CFR part 812 or 312.
  


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  For purposes of global support, the successful candidate to reside in Mountain or Pacific time zone.
  


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  Accepting Applications until April 7, 2025.
  

About the role



Cochlear is helping people hear, and be heard, all over the world. Come be a part of our amazing mission and join the number one most trustworthy company in the healthcare industry as recognized by Newsweek in its 2024 rankings of the World's Most Trustworthy Companies! If you know quality and compliance in the conducting of clinical research activities, this is a fantastic opportunity to join the Clinical Operations team at the global leader in implantable hearing devices! In this role, you will be based in the U.S., but reporting to Cochlear's head office located in Sydney Australia. If you are in the Denver area, you will be based in our Lone Tree office with a hybrid schedule of in-office 2 days per week and remote 3 days per week. If you are outside of the Denver area, you will be 100% remotely located in a US time zone west of Central time, with periodic travel to the Lone Tree office.


Your success in this role is measured by your ability to be an effective regional representative for this global function. You will be able to complete required responsibilities while championing practical understanding and application of applicable GXP (Good Clinical Practice, Good Documentation Practice, Good Vault Practice).



Key Responsibilities

• Enabling process owners in the development, maintenance and deployment of clinical research quality management processes that comply with applicable CAM regional regulations, global ethical and good clinical practice (GCP) standards and Cochlear's quality management system (QMS).


• Execution and support of quality control and quality assurance activities that monitor quality and compliance in the conduct of clinical research activities.


• Facilitating the implementation of clinical systems for electronic trial master file and clinical trial management.


• Support FDA inspections, internal Quality and conduct Clinical Studies audits; support corrective actions needed for any findings during audits.


• Support the implementation of new clinical research systems as needed to facilitate the development of the clinical infrastructure to enhance the efficient execution of compliant clinical research activities.

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:

• Bachelor's in healthcare, Life Sciences, Nursing, Public Health or equivalent.

• Minimum of 5 Years of relevant clinical research experience

• Working knowledge and experience in practical application of Good Clinical Practice principles.

• Working knowledge and experience in practical application of either pharmaceutical or medical device regulations including 21 Code of Federal Regulations Part 812 or 312.

• Experience providing subject matter contribution to the development or maintenance of quality management process development to align with GCP and applicable regulations.

• Experience contributing or leading to relevant quality or performance activities such as metrics, auditing, CAPA root cause or effectiveness monitoring, QMS implementation or transition planning.

• Prior experience with regulatory inspections.

Total Rewards



In addition to the opportunity to develop your knowledge and grow professionally, we offer competitive wages and benefits.

• Pay Range in the United States: $109,000 - $130,000 per year based upon experience, as well as an annual bonus opportunity of 15% of base salary. Exact compensation may vary based on skills, experience, and location.


• Benefit package includes medical, dental, vision, life and disability insurance as well as 401(K) matching with immediate vesting, Paid Time Off, tuition reimbursement, maternity and paternity leave, Employee Stock Purchase Plan and pet insurance.

Who are we?



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.



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. May be asked to occasionally transport/move up to 30 pounds, depending on the position. 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 or home office environment. This is representative of the environment an individual may encounter while performing the essential functions of this job.



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 Employer. We 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. Apply Now