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Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave
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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
- Eligibility for an annual performance bonus based on individual and corporate performance
- Comprehensive employee benefits including medical, dental, vision, and life insurance
- Opportunities for career advancement and participation in the company's long-term incentive program
- Generous time off benefits including vacation, sick time, and holidays
- Flexible work arrangements, including the option to work remotely
What to Expect (Job Responsibilities):
- Collaborate with marketing and sales personnel to review and provide guidance on advertising and promotional materials
- Maintain and train stakeholders on geography-specific advertising and promotion regulatory policies and procedures
- Conduct reviews of promotional materials to ensure compliance with relevant regulations and corporate policies
- Ensure that product labeling changes are reflected in current promotions and advertising
- Identify regulatory compliance vulnerabilities and develop corrective action plans as needed
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
- Minimum 1-2 years of experience in regulatory affairs reviews of advertising and promotional materials in a medical device environment
- Advanced knowledge of FDA guidelines and regulations, particularly related to promotional activities
- Proficiency in MS Word, Excel, and PowerPoint
- Ability to communicate effectively and negotiate with regulatory agencies
How to Stand Out (Preferred Qualifications):
- Experience with Class III medical devices and knowledge of worldwide advertising and promotional guidelines
- Strong analytical thinking and problem-solving skills
- Ability to manage multiple priorities in a fast-paced environment
- Experience in developing or maintaining advertising/promotion documents
- Demonstrated ability to work both independently and as part of a team
#HealthcareInnovation #MedicalTechnology #RegulatoryAffairs #CareerOpportunity #CompetitivePay
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