Program Manager I, Quality Compliance

Integra LifeSciences is a global medical technology leader in neurosurgery and regenerative medicine driven by our purpose of restoring patients’ lives. The company offers a broad portfolio of products and innovative solutions for dural access and repair, cerebral spinal fluid management and neuro-critical care. Its regenerative tissue technologies include products that address soft tissue, peripheral nerve and tendon repairs and for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery.

Founded in 1989 by Richard E. Caruso, the company is headquartered in Princeton, New Jersey. Today, Integra LifeSciences has grown immensely, with more than 4200 employees worldwide as well as offices, manufacturing and research facilities in Asia, Australia, Europe, Middle East, and the Americas.

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily including their overarching responsibility of overseeing the implementation of the ECMP at the sites, including:

• Developing and managing the site project plan;
• Reporting on the sites’ progress to the ECMP Project Manager;
• Being responsible for the site(s) ECMP documentation and schedule;
• Coordinating collaborative activities across the sites’ workstream activities;
• Other duties as assigned.

DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required for this position.

Education:

• Bachelor's degree is required, and engineering, science or closely related technical discipline is preferred.

Skills/Knowledge:

• 8+ years of experience leading program and project teams (including direct reports) or equivalent education and years of management experience is required.
• Experience in highly regulated industries required, medical device and/or pharmaceutical preferred, including material remediation experience.
• Experience in implementing remediation programs, and working with compliance frameworks such as FDA, ISO 13485, and EU MDR is required
• Strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education is required.
• Demonstrated organizational, management and communication skills is required.
• Proven track record of cross-functional collaboration across teams and change management skills is required.
• Strong communication and presentation skills, with the ability to articulate program status and risks to key stakeholders is required.
• Knowledge of process design and implementation, change control, auditing, and document management systems required, general knowledge of statistical analysis preferred.

Travel

• Ability to travel up to 50% if needed based on site needs. Regular on-site presence at designated facilities within scope of responsibilities.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA . If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected].