Manager, Quality Assurance & Regulatory Affairs - Englewood, CO

At Getinge we have the passion to perform

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows.

Every day we collaborate to make a true difference for our customers - and to save more lives.

Are you looking for an inspiring career? You just found it.

At Getinge, we exist to make life-saving technology accessible for more people. To meet future expectations and perform at our best, we need Team players, Forward thinkers and Game changers.

Getinge offers a generous benefit package (including access to health insurance, time off accruals and 401k participation - day of hire), a robust PTO program and fully supports the "work / life balance" philosophy.

Job Function Summary :

Is a Management Representative for quality system, responsible for maintaining compliant quality system, implementing new and updated product related regulatory requirements of applicable markets and jurisdictions, ensuring full audit readiness of the organization and leading a quality team.

This role requires strong leadership, technical expertise in quality assurance and regulatory affairs, and the ability to collaborate effectively with cross-functional teams.

Job Functions :

• Is a Management Representative according to ISO 13485 requirements
• Lead projects that impact the Quality Management System
• Identify and track actions and milestones arising from the Corrective and Preventive Action process, Audit findings, or

other Quality Management System process, as requested by Compliance leadership

• Report on progress against schedules, milestones, and project goals
• Respond to internal and external audit findings and assist in planning, corrections and prevention as needed.
• Develop, administer, and maintain the quality management system (QMS), including the Quality Manual, QMS

processes, and all documents & records that support the QMS

• Manage all aspects of audits by external agencies :
• Responsible for ensuring compliance of local audit support procedures to external regulations andstandards andcorporate procedures
• Responsible for ensuring record retention policies related to audit records are followed
• Complaint handling / Vigilance responsibility - maintenance of vigilance system in compliance with relevant regulations,

Medical Device Regulation (MDR) evaluation and reporting, complaint trending, and PMS activities

• Ship holds, recalls, field actions management, and blocking of non-conforming materials and products
• Maintenance, review, and implementation of standards and regulations affecting the product and the QMS
• Manage the corrective & preventive action system (CAPA)
• Provide regulatory guidance on business matters for the US and world markets, liaise with regulatory bodies, ensure

regulatory compliance, and manage all regulatory submissions & registrations

Responsible for continuous improvement, internal audits, and third-party audits for certifications and investigations,

and supports manufacturing, process validations, engineering, and supply chain

• Product release - ensuring product release in accordance with quality and regulatory requirements
• Supplier approval and management of supplier auditing system

Required Knowledge, Skills and Abilities :

• In-depth knowledge of ISO 13485 and FDA 21CFR820 requirements. Knowledge of EU MDR beneficial
• Analytical mindset with strong problem solving skills
• High level of attention to detail and accuracy
• Strong computer skills, including MS Office applications (Word / Excel) and Microsoft Project are required
• Proficiency in relevant software applications (e.g., document management systems, quality management systems) is

a plus

Demonstrated leadership experience with the ability to lead and develop a team, drive accountability, and foster a

culture of quality and compliance

Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams,

regulatory agencies, and external stakeholders

Minimum Requirements :

• Bachelor's Degree or equivalent work experience
• A minimum of four years related Quality Management experience in an FDA regulated environment

Quality Requirements :

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device

regulations (As applicable to the job function).

• Attend all required Quality & Compliance training at the specified interval.
• Adopt the "Beyond Compliance Quality Culture" in the work environment; always meet and exceed requirements.

Environmental / Safety / Physical Work Conditions :

• Daily use of computer / laptop and related accessories in an office environment
• Occasional work in controlled environment
• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer and telephone equipment and other related office accessories / devices to complete assignments.
• May work extended hours during peak business cycles.
• Hearing necessary to receive and reply to outside contacts and employees. Ability to speak clearly in order to

communicate with outside contacts and employees in person and on the telephone. Must be willing to work in a sitting

position for long periods of time.

Some bending, stooping, reaching and lifting (up to 15 pounds) is required. Willingness to frequently move to various

locations within and outside of the building.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Supervision / Management Of Others :

Responsible for the development and management of personnel and programs in the Quality and Regulatory department.

Disclaimer :

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

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About us

Getinge is on an excitingtransformation journey constantly looking for new ways to innovate together with our customersto meet the healthcare challenges of the future.

We are committed to diversity, equity and inclusion and to sustainability with a goal to beCO2 neutral by 2025.We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supportstheirpersonal development andcreativity.

Our passionatepeople hold our brand promise 'Passion for Life' close to heart.

Ifyoushareourpassionandbelievethatsavinglivesisthegreatestjobinthe world,thenwelook forwardtoreceivingyourapplication and resume.

We hope you will join us on our journey to become the world's most respected and trusted Medtech company.

Benefits at Getinge :

At Getinge, we offer a comprehensive benefits package, which includes :

• Health, Dental, Vision and Travel insurance benefits
• Retirement Plan with company match
• Personal Flex Time
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer. Getinge will, at all times, will comply with all applicable human rights and other legislation when considering all qualified applicants for employment.

Accommodations are available upon request for candidates taking part in all aspects of the selection process.