Job Description

• Partner with technical teams to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met
• Support the creation of regulatory submission documentation
• Strong understanding of regulations and standards affecting software medical devices such as IEC 62304, 21 CFR 820.30 and EU MDR
• Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills
• Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation)
• Practical experience in design control and risk management
• Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues
• Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities
• Strong oral and written communication skills, excellent interpersonal and cross-cultural skills required

Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.

In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact us. All applicants applying must be legally authorized to work in the country of employment.