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Senior Regulatory Affairs Specialist
vor 2 Monaten
This job offer is not available in your country.
Cochlear is the global market leader in implant hearing solutions.
Cochlear's mission is to help people hear and be heard.
Around the world, more people chose a Cochlear-branded hearing implant system than any other.
A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer from severe hearing loss.
It's an incredible piece of engineering and the only product in the world that restores a sense through technology.
Imagine using your experience to help people around the world to hear again.
We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions.
We are hiring for an enthusiastic Senior Regulatory Affairs Specialist to provide regulatory support throughout the lifecycle of Cochlear products.
Responsibilities In the pre-market phase, the Senior Regulatory Affairs Specialist provides advice to R&D cross-functional project teams on regulatory requirements and assesses acceptability of DHF documentation deliverables to ensure they are 'submission ready'.
In the post-market phase this role provides regulatory support to the sustaining engineering and manufacturing groups, specifically by assessing product and process changes and providing regulatory advice on required V&V and other supportive documentation.
In addition, the Senior Regulatory Affairs Specialist is responsible for preparing submissions to regulatory authorities such as FDA, EU notified bodies and in-country regulators, as required.
The role serves as a primary liaison between the regions and the project teams for regulatory inquiries, issue resolution and technical support.
Accountabilities Support project teams with Regulatory and standards compliance advice through product development.
Take responsibility and accountability for the development of the regulatory strategy to support business plans for a product or project.
Prepare and manage the submission process to gain new or modified products approval and maintain product licenses for the current product portfolio.
Develop and drive the implementation of plans and strategies to maintain product and relevant importation licenses / requirements throughout the product lifecycle.
Evaluate labeling and manufacturing changes and promotional material for regulatory impact and provide guidance.
Accurately describe changes for ease of agency review.
Inform the organization about new or changing national regulations / trends in responsible markets, proactively analyze the impact on the business and propose implementation plan options.
Drive the implementation of better regulatory practices and processes.
Follow relevant quality procedures to deliver quality products and services and identify and support the implementation of continuous improvement.
Lead the implementation and improvement of systems and process methods to improve deliverables.
Undertake additional quality responsibilities (e.g., audit) when appropriately trained to undertake these responsibilities.
Qualifications Bachelor's degree in engineering, legal, scientific or healthcare; or 3+ years' experience in software or product development, quality and / or regulatory affairs.
Excellent report writing and documentation skills and strong skills in influencing in a matrix team environment.
Ability to manage stakeholders at all levels within the business and work collaboratively in cross-functional teams.
Ability to make judgments and provide advice which balances the business interest and regulatory risk.
Able to make and be accountable for decisions when faced with ambiguity.
Ability to communicate and build relationships with regulators, as needed (FDA, TÜV, TGA, etc).
Relationship-building skills within the matrix team environment.
Ability to apply knowledge of global regulatory requirements for medical devices.
Regulatory Affairs Certification (RAC) highly desirable.
If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.
How we recognize your contribution We want Cochlear to be a place where our people truly enjoy coming to work.
Through our internal programs and employee benefits, we aim to create an environment where our people will feel valued and supported.
Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, we have several programs in place to support you.
At Cochlear, we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realize their full potential.
We offer flexible working arrangements, and we understand flexibility is not the same for everyone.
We're open to a conversation about what flexibility means for you.
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