Product Design Control Specialist

📋 Description

• Facilitate communication between Product and Regulatory teams to coordinate all product DHF deliverables.

• Manage timelines for product deliverables to ensure prompt release and submission.

• Develop and maintain project-specific technical file deliverable lists in accordance with internal SOPs.

• Ensure the use of appropriate templates for each deliverable and coordinate updates with the team.

• Collaborate with project leaders, RA, and Quality to clarify expectations for deliverable owners, provide guidance, and escalate risks when necessary.

• Monitor deliverables through company eQMS and ALM systems.

• Present product-related deliverables during inspections and internal/external audits.

• Assist in Jira–ALM integration and deliverable management.

• Consult with Product and Regulatory teams on content, interpreting regulatory intent and expectations.

• Incorporate regulatory feedback into the Product DHF and adjust tools or practices as needed.

• Support substantial equivalence evaluations and conformity assessments as required.

⛳️ Requirements

• Minimum 5 years of Quality Systems experience and Software as a Medical Device (SaMD) experience.

• At least 3 years in a regulatory project management or technical role.

• Background working in a regulated agile development environment.

• Knowledge of global medical device regulations: QSR/QMSR, MDD/CMDR/MDR.

• Experience with eQMS and ALM systems, including implementation of QMS requirements (Matrix experience preferred).

• Proficiency in ISO 13485, ISO 14971, IEC 62304, GDPR, HIPAA, and other international regulations/directives/standards.

• Direct involvement in product development.

• Project Management Institute (PMI) certification or equivalent credential.

🏝️ Benefits

• Choice of high-quality medical plan options with premiums covered for employees (subsidized coverage for dependents).

• Health coverage from day one.

• Short-term and long-term disability, as well as supplementary life insurance.

• 401(k) with immediate employer match vesting.

• Annual reimbursement for professional memberships.

• Opportunities for conference attendance and continued learning.

• Self-managed PTO and 10 paid holidays.

• Monthly internet stipend and one-time home office setup stipend.

• Fully remote work environment with virtual events and yearly retreats.