Senior Compliance Specialist

KRK Medtronic B.V.; Heerlen; In loco; EUR 65.000 - 98.000; Tempo pieno

Descrizione del lavoro

Medtronic is looking for a Sr. Process Compliance Specialist based in Heerlen, the Netherlands. The role emphasizes ensuring ongoing compliance with quality standards, regulations, and company policies across the S&R EMEA organization, and driving process improvements in a global setting.

The position requires 2 days on-site and relocation is not provided. You will lead compliance programs, facilitate reviews, provide data to management, monitor metrics, and support audits and inspections, all

Competenze

• Bachelor’s degree with a minimum of 4 years of relevant experience, or a Master’s degree with a minimum of 2 years of relevant experience in Quality, Compliance, or Process Improvement.
• Experience in medical device or similarly regulated industry.
• Fluent written and spoken English language.
• Experience in planning, coordinating, communicating, influencing, achieving milestones, resolving issues.
• Ability to work in a cross functional and global environment and cultural awareness.
• Good communication and interpersonal skills and ability to work independently.
• Proven experience in cross-functional stakeholder management.
• Project management skills.
• Good presentation skills.

Mansioni

• Ensure ongoing compliance of the S&R EMEA Organization to requirements originating from applicable Quality standards, regulations & policies.
• Facilitate Compliance Management reviews at prescribed intervals each fiscal year to review the continuing suitability, adequacy, and effectiveness of the S&R EMEA Organization’s Compliance strategies and programs.
• Provision of relevant information and data to S&R EMEA management, that facilitates evaluation of the adequacy and effectiveness of current compliance strategies and programs.
• Monitor compliance metrics and identify improvement opportunities.
• Collect and analyze data to identify root causes of compliance issues and performance shortfalls.
• Ensure timely and effective follow up of compliance actions (e.g. CAPA, Change Control, Regulatory actions etc.).
• Act as a Compliance SME ensuring a first-time right approach to activities affecting compliance to requirements.
• Support compliance audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.
• Prepare reports and/or necessary documentation to meet requirements and ensure applicable (internal and external) stakeholders are adequately informed.
• Plan, perform, and implement process improvement initiatives to enhance compliance and operational efficiency.

Descrizione del lavoro

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year.

Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life Join Medtronic’s Service & Repair (S&R) EMEA organization as a Sr. Process Compliance Specialist, where you will play a pivotal role in advancing compliance excellence across the region. If you are passionate about quality systems, continuous improvement, and enabling organizational success through compliance, this role offers broad visibility and meaningful impact. In this exciting role, you will play a critical role in ensuring ongoing compliance of the Service & Repair (S&R) EMEA organization with all applicable quality standards, regulatory requirements, and company policies. You will drive and implement process improvement initiatives, facilitate cross-functional teams, and act as a subject matter expert (SME) for compliance-related activities. Your work will directly support the organization’s mission to deliver high-quality, compliant, and efficient services across the EMEA region. The role is based in Heerlen, the Netherlands and will require 2 days on-site presence. Please note that relocation assistance is not provided.

Primary Responsibilities

• Ensure ongoing compliance of the S&R EMEA Organization to requirements originating from applicable Quality standards, regulations & policies.
• Facilitate Compliance Management reviews at prescribed intervals each fiscal year to review the continuing suitability, adequacy, and effectiveness of the S&R EMEA Organization’s Compliance strategies and programs.
• Provision of relevant information and data to S&R EMEA management, that facilitates evaluation of the adequacy and effectiveness of current compliance strategies and programs.
• Monitor compliance metrics and identify improvement opportunities.
• Collect and analyze data to identify root causes of compliance issues and performance shortfalls.
• Ensure timely and effective follow up of compliance actions (e.g. CAPA, Change Control, Regulatory actions etc.).
• Act as a Compliance SME ensuring a first-time right approach to activities affecting compliance to requirements.
• Support compliance audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.
• Prepare reports and/or necessary documentation to meet requirements and ensure applicable (internal and external) stakeholders are adequately informed.
• Plan, perform, and implement process improvement initiatives to enhance compliance and operational efficiency.

Required Qualifications

• Bachelor’s degree with a minimum of 4 years of relevant experience, or a Master’s degree with a minimum of 2 years of relevant experience in Quality, Compliance, or Process Improvement
• Experience in medical device or similarly regulated industry
• Fluent written and spoken English language
• Experience in planning, coordinating, communicating, influencing, achieving milestones, resolving issues
• Ability to work in a cross functional and global environment and cultural awareness
• Good communication and interpersonal skills and ability to work independently
• Proven experience in cross-functional stakeholder management
• Project management skills
• Good presentation skills

Preferred Qualifications

• Experience supporting remote employees and/or field sales
• Knowledge of local/country regulations
• Knowledge of Service & Repair or technical field service environments
• Experience working with audit/inspection readiness programs
• MAP Agile knowledge
• Lean or Six Sigma certification and experience
• Project Management certification and experience

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Netherlands: 65,040.00 EUR - 97,560.00 EUR | The final salary within this range will be determined based on objective, job-related criteria, including relevant experience, skills and qualifications, in accordance with our compensation framework. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA.

This is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.