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Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave


Pay$89000.00 - $143750.00 / year
LocationNew Brighton/Minnesota
Employment typeFull-Time

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  • Job Description

      Req#: 2406226089W
      Employer Industry: Healthcare Innovation and Medical Technology

      Why consider this job opportunity:
      - Salary up to $165,600
      - Eligible for an annual performance bonus based on individual and corporate performance
      - Comprehensive employee benefits, including medical, dental, vision, and life insurance
      - Opportunities for professional growth and development within a leading healthcare company
      - Flexible work environment with remote work options available
      - Generous paid time off, including vacation, sick time, and holidays

      What to Expect (Job Responsibilities):
      - Collaborate with marketing and sales teams to review and guide advertising and promotional materials for compliance
      - Maintain and train stakeholders on geography-specific regulatory policies and SOPs
      - Conduct regulatory reviews of promotional materials to ensure compliance with applicable guidelines
      - Identify compliance vulnerabilities and develop corrective action plans
      - Plan and manage projects, including meetings and timelines, under the guidance of regulatory affairs leadership

      What is Required (Qualifications):
      - Minimum 5 years of experience in a regulated healthcare industry with a Bachelor's degree; or 3 years with a Master's degree; or a PhD without experience
      - At least 1-2 years of experience in regulatory affairs reviews of advertising materials in a medical device environment
      - Advanced knowledge of FDA guidelines and regulations related to product promotional activities
      - Proficient in MS Word, Excel, and PowerPoint
      - Ability to communicate effectively and manage multiple priorities in a fast-paced environment

      How to Stand Out (Preferred Qualifications):
      - Degree in science, math, engineering, medical, or other technical fields and experience with Class III medical devices
      - Worldwide knowledge of advertising and promotional guidelines and regulations
      - Strong analytical and problem-solving skills
      - Experience negotiating with regulatory agencies
      - Ability to model inclusive behaviors within the organization

      #HealthcareInnovation #MedicalTechnology #RegulatoryAffairs #CareerGrowth #RemoteWork

      "We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer."
  • About the company

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