- Memphis, TN, 37501, US
- United States of America-Tennessee-Nashville
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Job description
We are currently seeking a Senior Regulatory Specialist to join our Foot & Ankle Division to be based in Memphis, Tennessee.
As the Senior Regulatory Affairs Specialist, you will provide regulatory support in Stryker’s Foot and Ankle business unit to obtain and maintain US and global market access. You will engage with cross-functional teams, develop global regulatory strategies, support regulatory submissions, interact with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluate proposed device changes.
What you will do
Develop and implement processes involved with maintaining annual licenses, registrations, and listings
Review and approve advertising and promotion to ensure regulatory compliance
Submit notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge
Provide regulatory input and appropriate follow-up for inspections and audits
Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
Assist in the development of regulatory strategy and updates strategy based upon regulatory changes
Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
Negotiate with regulatory authorities throughout the product lifecycle
Identify the need for new regulatory procedures, SOPs, and participates in development and implementation
Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
What you need
Bachelors Degree in Engineering, Science, or related area required
Minimum 2 years of experience supporting regulatory submissions required
Preferred
Masters in Regulatory Affairs
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