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Advanced Resource Managers are currently partnered with a client based in San Diego who are a leading Medical Device business who operate on a global scale. They are looking to hire a Principal Regulatory Specialist to join them on permanent basis.
The main purpose for this role would be to perform the coordination and preparation of documents for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements.
Main responsibilities will cover:
- Prepare submissions to obtain and maintain global regulatory approvals of products, including, FDA (510k Submissions), EU Technical Documentation Files and health Canada Application Submissions.
- Ability to work with senior management supporting activities required to ensure that products are in full compliance with U.S. and all applicable international regulatory requirements
- Support in reviewing and approving device labeling and advertising/promotional materials to ensure continued compliance to global regulations.
- Provide regulatory guidance and direction as a core team member on manufacturing and development teams throughout the product life-cycle.
- Develop and implement regulatory strategies for new and modified products
- Recommend strategies at the earliest possible stage to approvals of clinical trials applications.
- Act as representative, developing and maintaining positive relationships with regulatory agency reviewers regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
- Provide expertise and guidance in interpreting regulations and agency guidelines
To be considered for this role you will need to have the following:
- Broad expertise to contribute to develop company objectives
- Have the ability to work on significant and unique issues where analysis of situations or data
- Bachelor's degree, preferably in a scientific or technical discipline
- 6+ years Regulatory Affairs medical industry experience preferred
- Prove track record in management of regulatory submissions
- Extensive understanding of global regulations
- Expansive knowledge of product development process and design control
- Ability to manage multiple projects
This role is looking to pay a competitive salary as well as a full benefits package. If you are interested in this role please email me on firstname.lastname@example.org
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