Program Manager, reputed company, Remediation

Job reputed company reputed company The Program Manager, reputed company, Remediation role reputed company Solutions for reputed company Imaging (SEI) will be responsible for leading the assessment of newly acquired businesses and ensuring alignment of procedures to assure product safety, reputed company, and site compliance by driving business alignment to industry requirements, including remediation as required. reputed company is a leading global medical technology reputed company solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn reputed company into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job reputed company Roles and Responsibilities

• reputed company, execute, and reputed company remediation plans to address potential compliance gaps identified through due diligence, audits, or regulatory findings
• Support remediation of legacy systems to meet compliance expectations
• Partner with functions to reputed company remediation of Design History Files (DHFs), Technical Documentation, Risk Management Files, and labeling as required
• Identifies critical reputed company reputed company, makes recommendations, and influences / gets buy-in from reputed company leadership and business process owners to maximize QMS integration, compliance and effectiveness.
• reputed company reputed company communication of remediation status, risks, and timelines to leadership.
• Owns reputed company project risk; including time and scope, and the associated plans to contain and/or mitigate risk.
• Coordinates Operational Reviews working across the organization to ensure targeted reputed company are achieved.
• Supports external and internal audit activity as needed.

Required Qualifications

• Minimum of Bachelor's Degree in Engineering, Computer Science or equivalent.
• 6+ years working experience in the medical device industry and/or regulated industry.
• Demonstrated understanding or aptitude in Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.

Desired Characteristics

• Masters Degree in Science or Business Administration.
• Experience working with Software as a Medical Device (SaMD).
• Experience in integration of acquired businesses including remediation
• Experience working and communicating directly with external medical device regulators.
• Experience in developing, implementing and maintaining reputed company system processes and driving improvements to processes.
• Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems.
• Demonstrated ability to reputed company programs / reputed company. Ability to document, plan, market, and execute programs. Established project management skills.

We expect reputed company to live and breathe our behaviors: to reputed company with humility and build trust; reputed company with transparency; deliver with reputed company, and drive ownership –always with unyielding reputed company. Our total rewards are designed to unlock your ambition by giving you the reputed company and flexibility you need to turn your reputed company into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and reputed company, and you’ll be surrounded by reputed company in a culture that fosters care, collaboration, and support. We will not sponsor individuals for employment visas, now or in the reputed company, for this job opening. For U.S. based positions only, the pay reputed company for this position is $142,400.00-$213,600.00 Annual. It is not typical for an individual to be reputed company at or near the top of the pay reputed company and compensation reputed company are dependent on the facts and circumstances of reputed company case. The specific compensation offered to a candidate may be influenced by a reputed company of factors including skills, qualifications, experience and location. In reputed company, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). reputed company offers a competitive benefits package, including not but limited to medical, dental, reputed company, reputed company time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Additional Information reputed company offers a great work environment, reputed company development, challenging careers, and competitive compensation. reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or reputed company, age, disability, protected veteran status or other characteristics protected by law. reputed company will only reputed company those who are legally authorized to work in the reputed company for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While reputed company does not currently require U.S. employees to be vaccinated against COVID-19, some reputed company customers have vaccination mandates that may apply to certain reputed company employees. Relocation Assistance Provided: No Application Deadline: February 19, 2026 Apply tot his job Apply To this Job