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 facilitates valuable and productive conversations between you and potential employers. We can assist you in growing your career by partnering you with employers that offer challenging assignments. For those that join the team, we offer competitive compensation and benefits including medical, dental, vision, and retirement. Check out all we have to offer and how you can become part of the Horizontal Talent Team. The pay range for this role is $81 - $90 per hour. This is not a guarantee of compensation, as final offer amount may vary based on factors including but not limited to experience and geographic location.
