Sr Regulatory Affairs Specialist (Remote) - Shockwave

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

Job summary

A leading company in healthcare innovation is seeking an experienced Regulatory Affairs Specialist. The role entails ensuring compliance with regulatory requirements for medical devices, managing submissions, and developing strategies aligned with business priorities. This opportunity offers competitive pay and comprehensive benefits in a supportive environment focused on innovation.

Benefits

Comprehensive employee benefits including medical, dental, vision, and life insurance

Eligible for an annual performance bonus

Generous time off benefits

Opportunity to participate in long-term incentive program

Qualifications

• Minimum 5 years in regulatory affairs for medical devices.
• Experience with submissions like 510(k), IDE, PMA, and EU Technical Files.
• Knowledge of regulatory guidelines and policies.

Responsibilities

• Collaborate with internal departments to meet regulatory requirements.
• Develop regulatory strategies and ensure compliance.
• Prepare regulatory submissions to authorities in the US and EU.

Skills

Regulatory compliance

Project management

Verbal communication

Written communication

Education

Bachelor’s degree in related field

Master’s degree in related field

PhD in related field

Tools

MS Word

Excel

Adobe

PowerPoint

Job description

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
- Opportunity to participate in the Company's long-term incentive program
- Generous time off benefits, including vacation, sick time, and holiday pay
- Work in a supportive and innovative environment focused on developing cutting-edge medical solutions

What to Expect (Job Responsibilities):
- Collaborate with various internal departments to meet regulatory requirements for medical devices
- Develop regulatory strategies in alignment with business priorities and ensure compliance with regulations
- Prepare and submit high-quality regulatory submissions to authorities in the US and EU
- Review and approve documentation for research and development, quality, and clinical purposes
- Communicate progress on regulatory applications to internal stakeholders and negotiate with regulatory authorities

What is Required (Qualifications):
- Minimum 5 years of regulatory affairs experience in the medical device industry with a Bachelor's degree, or 3 years with a Master's degree, or a PhD without experience
- Experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, and EU Technical Files
- Strong knowledge of domestic and international regulatory guidelines and policies
- Excellent verbal and written communication skills with diverse audiences
- Ability to manage multiple projects and prioritize tasks effectively

How to Stand Out (Preferred Qualifications):
- Experience with international filings such as TGA, Health Canada, Shonin, and CFDA
- Some background in medical device software engineering
- Proficiency in MS Word, Excel, Adobe, and PowerPoint

#HealthcareInnovation #MedicalDevices #RegulatoryAffairs #CareerOpportunity #CompetitivePay

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