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

Talentify.io; United States; Remote; USD 140,000 - 166,000; Full time

Job summary

A rapidly accelerating company in Healthcare Innovation seeks a Regulatory Affairs professional. The role includes compliance reviews of promotional materials within medical devices, offering a lucrative salary, performance bonuses, and comprehensive benefits. Engage in meaningful work that directly impacts health and wellness while enjoying the flexibility of remote work.

Benefits

Comprehensive employee benefits

Generous paid time off

Flexible remote work options

Annual performance bonus

Qualifications

• 5+ years in a regulated healthcare industry or 3+ years with a Master's degree.
• Advanced knowledge of US & international medical device promotion regulations.
• 1-2 years conducting regulatory affairs reviews in medical devices.

Responsibilities

• Collaborate with marketing/sales on compliance reviews.
• Conduct global regulatory reviews for compliance.
• Identify compliance vulnerabilities and develop corrective plans.

Skills

Regulatory compliance

Effective communication

Analytical skills

Problem-solving skills

Education

Bachelor's degree in related field

Master's degree

PhD

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Employer Industry: Healthcare Innovation

Why consider this job opportunity:
- Salary up to $165,600
- Opportunity for an annual performance bonus based on individual and corporate performance
- Comprehensive employee benefits, including medical, dental, vision, and retirement plans
- Generous paid time off, including vacation, sick leave, and holidays
- Work remotely with flexibility in location
- Engage in pioneering work on innovative medical devices that can profoundly impact health for humanity

What to Expect (Job Responsibilities):
- Collaboratively interface with marketing and sales teams to review advertising and promotional materials for compliance
- Research and maintain advertising and promotion regulatory policies and assist in training internal stakeholders
- Conduct global regulatory reviews to ensure compliance with applicable regulations and corporate policies
- Collaborate with internal stakeholders to ensure accurate representation of product labeling in promotional material
- Identify regulatory compliance vulnerabilities and assist in developing corrective action plans

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 with 1 year of experience
- Minimum 1-2 years of experience in conducting regulatory affairs reviews of advertising and promotional material in a medical device environment
- Advanced knowledge of US and international medical device promotion regulations and guidelines
- Proficiency in MS Word, Excel, and PowerPoint
- Ability to communicate effectively and work collaboratively in a fast-paced environment

How to Stand Out (Preferred Qualifications):
- Experience with the development and maintenance of advertising/promotion documents such as core claims documents
- Background in Class II/III medical device experience
- Strong analytical and problem-solving skills
- Experience negotiating with regulatory agencies
- Ability to demonstrate flexibility to changing requirements

#HealthcareInnovation #RegulatoryAffairs #MedicalDevices #CareerOpportunity #RemoteWork

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