Senior Regulatory Affairs Specialist, Mako and Enabling Technologies (Hybrid)
Senior Regulatory Affairs Specialist, Mako and Enabling Technologies (Hybrid)
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$ 87600 - 148400
1 Vacancy
Job Description
We are seeking a Senior Regulatory Specialist to join our Mako and Enabling Technology business within the Joint Replacement Division to be based hybrid two to three days per week in Mahwah NJ or Weston FL.
What you will do
As the Senior Regulatory Affairs Specialist you will support Strykers Mako and Enabling Technology portfolio new product development for both US and OUS Global Regulatory release. Mako and Enabling Technologies portfolio covers three technology pillars robotics navigation and imaging which includes capital equipment navigation robotics software devices and/or associated accessories and instruments and provides unique opportunities to collaborate across various Stryker divisions. You will participate in cross-functional teams develop global regulatory strategies author regulatory submissions interact with regulatory agencies/notified bodies review labeling and marketing material and evaluate proposed device changes.
Assess regulatory landscape to create the development of global regulatory strategies
Identify requirements and anticipate regulatory obstacles for market access distribution and update regulatory strategy based on changes.
Determine requirements and options for regulatory submission approval pathways and compliance activities.
Provide regulatory information and guidance during product development planning and review proposed product claims/labeling throughout the product lifecycle.
Work with regulatory authorities and track review progress through clear communication.
Identify the need for new regulatory procedures SOPs and helps train stakeholders to ensure organization-wide compliance.
Prepare and submit electronic submissions ensuring consistency with regulatory requirements.
What you need
Bachelors Degree in Engineering Science or related
3 years of experience in an FDA regulated industry
2 years of experience in medical device regulatory affairs
Thorough understanding of FDA Europe and international medical device regulations
Experience drafting regulatory submissions for product approval
Preferred
RAC certification or Advanced Degree (Masters in Regulatory Affairs)
Previous experience with Class II/III medical devices
Previous experience drafting 510(k)s
Experience interacting with regulatory agencies
$87600.00 - $148400.00 salary plus bonus eligible benefits. Actual minimum and maximum may vary based on pay is based on skills experience and other relevant factors.
Travel Percentage: NoneStryker 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 contractors legal duty to furnish information.Required Experience:
Senior IC
Employment Type
Full-Time
