Medical Device, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
4 Year Degree
Job Title:Senior Regulatory Affairs Specialist
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 Senior Regulatory Affairs Specialist in our Americas’ office based in Centennial, Colorado.
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.
Create regulatory submissions to the FDA and Health Canada including PMAs, PMA supplements, 510(k)s, and pre-submission meeting requests within agreed timelines.
Liaise with health authorities as needed to meet project goals.
Manage assigned post-approval reporting obligations in the areas of progress reports for post-approval studies and other conditions of approval.
Assess proposed manufacturing or product changes with an appropriate level of justification.
Work with Studies and Research groups to secure approval for Investigational Device Exemptions and coordinate the creation of required progress reports.
Coordinate and recommend changes to sales and marketing literature, product labels, and Cochlear’s website to ensure regulatory compliance.
Working at Cochlear Americas:
Work with dedicated and passionate colleagues to help more people hear
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 (onsite gym, dry cleaning services and more)
Apply now by completing your application form online. Cochlear is an equal employment opportunity organization. Applicants must meet the job specific application criteria to be considered.
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 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 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.
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
5+ years of regulatory experience in a medical device or pharmaceutical company
Experience in management, compilation, and submission of regulatory submissions
Excellent written and oral communication skills
Demonstrated analytical thinking skills to identify and resolve problems
Ability to work with cross functional teams in a commercial environment
Computer literate with experience in Microsoft Office
Advanced degree in the health sciences or RAC certification
Proven track record of management, compilation and submission of regulatory submissions
Thorough knowledge of U.S. and Canadian regulations regarding Class II and Class III medical devices
Additional Salary Information: Eligible for bonus
Internal Number: 608795
About Cochlear Americas
Cochlear is the leading global expert in implantable hearing solutions. For more than 30 years, Cochlear has helped over 550,000 people connect to the world of sound. With a global team of over 3,500 passionate experts, Cochlear is an organization you can be proud to work for. Our employees say making a difference in the lives of others is the number one reason they enjoy working at Cochlear.