Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Position Spotlight:

• Whatyoullneed:Minimum5 years of regulatory experience and a strong background in FDA submission writing

• Whatyoulldo: Help to develop support and execute regulatory strategies for all product lines

• Location: Hybrid work environmentoperatingout of our head office in Lone Tree CO

About the role

The role of Senior Regulatory Affairs Specialist contributes to achieving Cochlears business outcomes by providing regulatory support and guidance to help bring innovative products to our customers and helping ensure that Cochlear is compliant with premarket and post market regulatory requirements for all medical devices. This role will work closely with colleagues based at the legal manufacturers and colleagueslocatedin North America. The Senior Regulatory Affairs Specialist will support guideand lead projectsin order tomeet the regional priorities.

Key Responsibilities

• Ensure company business plans are met bysubmittingregulatory applications within agreed timelines. Be able to link the impact of Regulatory activities with other departments and proactively communicate and relevant information.

• Independently write executive summaries and compile documents for submissions of all types for FDA and Health Canada.Ensure thatsubmissions andfollow upactivities are of high quality leading totimelyapprovals.As the main contact for your written submissions liaise with health authorities as needed to meet project goals.

• This mayinclude facilitating conference calls and documenting all written correspondence andface to facemeetings. Actively cultivate a good relationship with regulatory authority personnel.

• Work with the Clinical Studies and Research & Development teams to secure approval for any studies requiring an Investigational Testing Authorization or Investigational Device Exemption. Coordinate the creation of required progress reports and help ensure required reports aresubmittedon time. Provide basicassistancewith study design to ensure the studywill meetthe needs of regulators and lead toa successfulmarketing authorization.

• Represent Regulatory on cross functional product launch teams and serve as subject matter expert and key contact.

• Manage assigned postapproval reporting obligations in the areas of progress reports for postapproval studies and other conditions of approval. Support post market requirements related to CAPAs or field actions. Ensure documentation is kept up todateand that applicable procedures are followed.

Key Requirements

To add value to Cochlear in this roleyoullbe able tomeet anddemonstratethe followingknowledgeskillsand abilitiesin your application and at interview:

• BachelorsDegree

• Ideal candidate willpossessan advanced degree in a scientific technical or engineering field

• 5 years regulatory experience

• Thorough knowledge of Health Canada and Food and Drug Administration requirements as they relate to Class II and Class III medical devices

• Demonstrated analytical thinking skills toidentifyand resolve problems.

• Demonstrated experience in the managementwritingand compilation of a regulatory submission.

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:$120000 - $130000based uponexperienceas well as an annualbonusopportunityof7.5%of base salary. Exact compensation may vary based on skills experience and location.

• Benefit package includes medical dental visionlifeand disability insurance as well as 401(K) matchingwith immediate vesting Paid Time Off tuition reimbursement maternity andpaternity leave Employee Stock PurchasePlanand 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 productsservicesand 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 peoples 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 describedbeloware 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 jobtheindividualisregularly 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 tooccasionally transport/move upto 30 pounds depending on the position.Specific vision abilities required by this job includeabilityto adjust focus. Theindividualis regularly required toutilizecomprehensioncritical thinking communication problem solving organizationreasoning relating to others and discernment of items such asproduct specificationsproceduresand processes to customers (whether internal or external).Influenceorganization/classification of information and planning are also.