Staff Regulatory Affairs Specialist (Pharmaceutical Products)
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Job Summary
Stryker is seeking a Staff Regulatory Affairs Specialist (Pharmaceutical Products) to join our Medical Division. This is a hybrid role based in Cary IL.
As the Staff Regulatory Affairs Specialist you will provide information used to evaluate proposed products for regulatory classification and jurisdiction. You will research requirements (local national international) applicable guidance and standards and options of regulatory submissions approval pathways and compliance activities.
What you will do
Prepare and author annual reports and other regulatory submissions required for approved pharmaceutical products.
Assess product process and manufacturing changes to determine appropriate regulatory reporting requirements and submission pathways.
Develop and submit amendments supplements and other regulatory filings in accordance with applicable regulations and guidance.
Review technical documentation and regulatory content to ensure accuracy completeness and submission readiness.
Research regulatory requirements standards guidance documents and approval pathways to support product development and lifecycle management.
Communicate with regulatory agencies regarding submission strategies regulatory pathways submission status and responses to agency inquiries.
Partner with engineering quality clinical manufacturing and marketing teams to support regulatory objectives during product development and sustaining activities.
Develop and communicate regulatory guidance requirements and compliance considerations to support business and project goals.
What you need
Required
Bachelors degree in Science Engineering Regulatory Affairs or a related discipline.
Minimum 4 years of experience in an FDA-regulated or other highly regulated industry.
Minimum 2 years of Regulatory Affairs experience within the medical device and/or pharmaceutical industry.
Experience reviewing regulatory requirements and assessing regulatory impact of product process or manufacturing changes.
Experience preparing authoring or supporting drug regulatory submissions including submissions for product approvals post-approval changes or lifecycle management activities.
Preferred
Regulatory Affairs Certification (RAC) or Masters degree in Regulatory Affairs or a related field.
Experience preparing or supporting international regulatory submissions and registrations.
Experience interacting directly with regulatory agencies.
- US10: $105300 - $175500 USD Annual
Required Experience:
Staff IC
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
