Senior Regulatory Affairs Specialist; Hybrid

Senior Regulatory Affairs Specialist (Hybrid) page is loaded## Senior Regulatory Affairs Specialist (Hybrid) locations:
Portage, Michigan time type:
Full time posted on:
Posted Todayjob requisition :
R557416

Work Flexibility:
Hybrid We are currently seeking a
** Senior*
* ** Regulatory Affairs Specialist
** to join our
** Acute Care
** business unit based
** hybrid
* * three days per week in
** Portage, Michigan**.
** What you will do
** As the
** Senior Regulatory Affairs Specialist**, you will support Stryker’s Acute Care portfolio for our global market. You will be responsible for maintaining global market access by analyzing the impact of device modifications and emerging regulatory intelligence. You will help identify global regulatory requirements to support new product development. You will enable global product sales in new markets by liaising with global Stryker teams to execute registrations in accordance with health authority requirements.
* Evaluate device modifications and takes appropriate action to ensure global product compliance.
* Support new product development in submitting registrations and subsequently support registration renewals in global markets.
* Analyze and advise on the impact of emerging regulatory intelligence.
* Provide regulatory input and technical guidance on global regulatory requirements to product development teams.
* Determine requirements and options for global regulatory submissions, approval pathways, and compliance activities.
* Prepare and submits regulatory submissions according to applicable regulatory requirements and guidelines in global markets.
* Participate in preparation and execution of audit required to enable of maintain market access.
* Identify the need for new regulatory procedures, SOPs, and participates in development and implementation.
** What you need
**** Required
* ** Bachelor's degree
* 2+ years of experience in an FDA or highly regulated industry
* 2+ years of full-time work experience in Regulatory Affairs and/or Quality Systems
* Demonstrated ability to analyze and resolve non‑routine regulatory issues using independent judgment.
* Ability to manage multiple priorities and adapt to changing regulatory requirements.
** Preferred
* ** Bachelor's degree (B.S. or B.A.) in Science, Engineering, or a related discipline Experience supporting Class II and/or Class III medical devices
* Experience authoring or supporting FDA 510(k) submissions
* Prior experience interacting directly with regulatory agencies
* Experience authoring global regulatory submissions for product approval
* RAC certification or an advanced degree (e.g., Master’s in Regulatory Affairs)

Travel Percentage : 10%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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