Sr. Manager Regulatory Quality

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.

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.

Job Overview

The Sr. Manager, Regulatory Affairs for Getinge's Talis Clinical product area will be responsible for partnering with R&D, Marketing, and Cybersecurity Teams as well as other cross-functional team members to develop and implement global regulatory strategies to drive pipeline development and global launch excellence. This position will manage and direct (1) the Talis Quality Management System, (2) the Talis Regulatory Strategy including early involvement with projects to identify the most effective alignment of product design and regulatory pathway required to achieve customer requirements, (3) preparation, submission, tracking of official documents and files such as Technical Documentation and other applicable country regulatory submissions and requirements, and (4) the Talis Information Security Management System. This position will also be responsible for management and development of quality, regulatory, and/or information security staff members.

Job Responsibilities and Essential Duties

• Develop and oversee the implementation of strategies for new product development and life cycle design and manufacturing improvements to obtain and maintain global product licenses. The Talis regulatory team is directly responsible for U.S. FDA submissions and support of global licensing.
• Pro-actively ensure strategies are adapted to changing regulatory requirements, provide robust input to project teams to drive predictability of regulatory timelines, and raise awareness of potential issues and risks early and to appropriate stakeholders, including providing regulatory solutions for Talis.
• Ensures the quality of technical files generated. Provides expertise and consultation on proper preparation of required documentation and files to Talis team members. Liaises with internal organizations to provide/solicit guidance and support for proper documentation and record keeping.
• Leverage a deep scientific and technical understanding of products to provide strategic guidance and support for product development, life-cycle management of products to fulfill customer requirements.
• Assures that a positive working relationship is developed and maintained with internal/external customers.
• Ensures continued certification to current versions of ISO 13485 and ISO 27001.
• Leads or assists internal and external regulatory (health and cybersecurity) authority / certification audits.
• Manage and direct the Talis CAPA process.
• Develop and maintain effective relationships with customers, regulatory agencies, business partners, and Talis team members by earning the reputation of consistently demonstrating transparency and honesty.
• Encourage and lead others to find ways to continuously improve, learn about new scientific, technological, regulatory, and cybersecurity developments, develop new capabilities and learn from past challenges and experiences in order to proactively adapt to change and drive innovative thinking.

Minimum Requirements

• A bachelor's degree in engineering, Science or related field is required. A Master of Science in Engineering, Science or related field or MBA is preferred.
• A minimum of ten years regulatory experience is required.
• People Leadership experience, including management direct reports and developing team members, is required.
• Experience leading interactions with global Regulatory Authorities is required, including leading and/or assisting with Health / Cybersecurity Authority audits.
• Interest in developing and executing successful regulatory / cybersecurity strategies is required.
• Working knowledge and experience withstandards management.
• Must have Competent Authority and Notified Body interaction experience.
• Must have in depth knowledge of global medical device and software as a medical device (SaMD) regulatory[WM1] requirements.Must have solid knowledge and experience in matters relating to organizational skills and personnel management.
• Must demonstrate effective written and verbal communication skills, including technical writing skills.
• Must have demonstrated ability to mentor, develop and influence team members.

Valuable Intangibles

• Proven problem solver
• Conceptual learner
• Reliance on influence to lead
• Focus on earning Customer Loyalty by turning negative experiences into positive experiences.
• Visionary leader that can provide a vision they are committed to with the passion to stay the course.

The base salary for the position is a minimum of $172,000 and maximum salary of $196,000 plus annual bonus of 25%

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. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

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.

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.