Senior Regulatory Affairs Specialist

7 days ago

Kent, Ohio, United States Stryker Full time
Job Title: Senior Regulatory Affairs Specialist

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our Acute Care business unit in Portage, Michigan.

About the Role:

This is a key position that will support Stryker's global market access by analyzing the impact of device modifications and emerging regulatory intelligence.

Key Responsibilities:
  • Maintain global market access by analyzing the impact of device modifications and emerging regulatory intelligence.
  • Identify global regulatory requirements to support new product development.
  • 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 take 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 submit regulatory submissions according to applicable regulatory requirements and guidelines in global markets.
  • Participate in preparation and execution of audit required to enable or maintain market access.
  • Identify the need for new regulatory procedures, SOPs, and participate in development and implementation.
Requirements:
  • A minimum of a Bachelor's Degree (B.S. or B.A.) in Science, Engineering or equivalent focus required.
  • A minimum of 2 years of experience in an FDA or highly regulated industry required.
  • A minimum of 2 years in a Regulatory Affairs role required.
  • Previous experience with Class II/III medical devices preferred.
  • Previous experience drafting 510(k)s preferred.
  • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
  • Experience authoring regulatory submissions for product approval preferred.
  • Experience interacting with regulatory agencies preferred.
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
  • Ability to analyze and resolve non-routine regulatory issues using independent judgment.
  • Excellent analytical and writing skills.
  • Excellent interpersonal, written and oral communication skills.
  • Effective organizational skills.
  • Advanced PC skills with proficiency in Microsoft office Suite, including Excel.
What We Offer:

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.

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