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Summary
About the Role
About You
- 5+ years of experience in medical device or a semi-regulated industry (8+ preferred).
- Strong background in software development and design assurance.
- In-depth knowledge of ISO 14971, IEC 62304, ISO 13485, 21 CFR Part 820, EU MDD/MDR, GDPR, IEC 60601.
- Proficiency in software development tools and languages (e.g., C++, C#, Python).
- Experience with version control, bug tracking, and automated test tools.
- Experience in software-related risk assessments, CAPAs, and design reviews in a regulated environment.
- Bachelor’s degree in science or engineering required.
- Excellent documentation and communication skills.
- Organized, detail-oriented, and able to manage cross-functional coordination.
- Demonstrated leadership potential and strategic thinking.
- Proficient in data entry, ERP systems, and quality/compliance documentation.
Benefits
- Compensation: $82,500 - $107,200 + 10% bonus + $20,000 RSUs.
- Relocation Assistance: Available.
- Sponsorship: Available.
Founded in 2012, Planet Pharma has a dedicated team of seasoned professionals with extensive experience supporting the Life Sciences industry, specifically: - Pharmaceuticals - Biotechnology - Medical Device & Diagnostics - Clinical Research Organizations (CROs) - CMOs / CDMOs - Specialty Providers - Labs & Healthcare Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent — ultimately making staffing more personal and creating enduring, valuable relationships. We achieve this by leveraging cutting-edge technology and flexible service delivery models that enable us to provide personalized solutions for your business. Planet Pharma has offices throughout North America, Europe, and APAC. All locations operate with shared attributes at the heart of everything we do! We provide the following solutions: - Contract & Direct Hire (Permanent) Staffing - Strategic Resourcing - Retained & Executive Search - Functional Service Provider (FSP) - Global Workforce Solutions