Principal Compliance Specialist

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

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

Ideal candidate will be local to Wayne, NJ site- hybrid on-site

• Job Overview
• Responsible for leadership and strategic support for global complaint handling and vigilance process improvement, associated CAPA ownership and execution, oversight, and implementation of new and changing regulation, and Designated Complaint Unit training content creation and deployment. Also responsible for leading, coordinating and drafting responses to regulatory Inquires in partnership with subject matter experts within the businesses.
• Job Responsibilities and Essential Duties
• Supports compliance with Food and Drug Administration (FDA), Organization of International Standards (ISO), Quality System Regulation, and other applicable regulatory requirements, as they relate to the complaint handling processes.
• Leads/Coordinates and/or completes internal/external risk assessments in accordance with regulatory standards, which may include US and/or international regulatory agencies / authorities.
• May lead/participate/support internal and external audit activities.
• Leads and or participates in Corrective and Preventive Action teams related to complaint handling and vigilance.
• Analyzes audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.
• Develops and implements programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes.
• Interprets and implements applicable regulations as they apply to products, processes, practices, and procedures.
• May counsel stakeholders about these requirements as necessary.
• Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.
• Regulatory presentations, summary reports, and meeting attendance, including changes to complaints database functionality as needed to maintain compliance.
• Coordinate and/or provide input in requests from US and/or OUS regulators, as required.
• Contributes to team effort by accomplishing related duties as requested.
• May be responsible for entire projects or processes within job area
• Required Knowledge, Skills and Abilities
• Bachelor's degree in an Engineering, Life Science, or related discipline, or equivalent work experience.
• Minimum of 7 years' experience in regulatory/quality complaint handling - in a pharmaceutical or medical device company.
• Project management and/or process mapping experience is preferred.
• Knowledge of general quality management system concepts, including good documentation practice (GDP) corrective and preventive action (CAPA) and document change control practices.
• Critical thinking and investigation skills. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
• Experience with the Quality System Regulation and ISO 13485 Quality Management System Standards.
• An ideal candidate will have a combination of process expertise, regulatory knowledge of medical devices (Especially - complaint handling, regulatory reporting), and project management skills.
• Seasoned individual contributor. Must be self-motivated, highly organized, and have the ability to handle multiple tasks and responsibilities.
• Strong interpersonal and communication skills with creative problem solving abilities.
• High level of customer service.
• Familiarity with OneTrack (Trackwise) is preferred.
• Coaches and reviews the work of peers; may manage projects / processes.
• Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.
• Proficient in the Microsoft Office (Word, Excel, PowerPoint)

The base salary for the position is a minimum of $116,000 and a maximum of $150,000, plus an annual bonus of 15% (depending on location)

#LI-Hybrid

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

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