Franchise Quality VP — Regulatory Strategy Leader

B. Braun Melsungen AG; Allentown (Lehigh County); Hybrid; USD 260,000 - 290,000; Full time

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. is seeking a senior quality leader in Allentown, PA to oversee global quality assurance functions across device programs.

The role focuses on aligning design control, risk management, and compliance with 21 CFR 820, ISO 13485, EU MDR, and post‑market surveillance requirements. The position requires extensive experience in quality management, regulatory interactions, and leadership across units, with hybrid work and a strong commitment to continuous improvement and patient

Qualifications

• Bachelor's degree required, Master's degree preferred.
• Minimum of 10 years related experience required, with at least 7 years of quality management experience.
• Applicable industry/professional certification preferred.
• Occasional business travel required

Responsibilities

• Provide strategic leadership for all franchise Quality Assurance functions to ensure compliance with global medical device regulations.
• Coordinate FDA‑required and global post‑market surveillance activities in partnership with PMS.
• Develop and manage the franchise quality budget and staffing.
• Serve as primary liaison with regulatory authorities during inspections, audits, and communications.

Job description

B. Braun Medical Inc. is seeking a senior quality leader in Allentown, PA to oversee global quality assurance functions across device programs.

The role focuses on aligning design control, risk management, and compliance with 21 CFR 820, ISO 13485, EU MDR, and post‑market surveillance requirements. The position requires extensive experience in quality management, regulatory interactions, and leadership across units, with hybrid work and a strong commitment to continuous improvement and patient