Senior Manager Regulatory Affairs (Wayne, NJ)

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 Cardiac Assist product area within our global Acute Care Therapy business area will be responsible for partnering with R&D and Marketing 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 the preparation, submission, tracking of official documents and files such as submission of 510(k) Notifications, Technical Documentation and other applicable country regulatory submissions and requirements. Manages and develops regulatory department specialist staff.

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 Cardiac Assist regulatory team is directly responsible for U.S. FDA submissions and EU Notified Body submissions.
• 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 the Cardiac Assist product area.
• Ensures the quality of submissions generated. Provides expertise and consultation on proper preparation of submission documentation and files to relevant departments. Liaises with internal organizations to provide/solicit guidance and support for complex submissions.
• Leverage a deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products.
• Assures that a positive working relationship is developed and maintained between staff and internal/external customers.
• Leads or assists with internal and external health authority audits for Regulatory department.
• Oversees and/or owns CAPAs pertaining to Regulatory department.
• Develops and maintains high level relationships with key contacts in regulatory agencies and trains junior team members on effective Health Authority meetig techniques and preparation.
• Encourage and lead other to find ways to continuously improve, learn about new scientific, technological and regulatory developments, develop new capabilities and learn from past challenge and experience in order to proactively adapt to change and drive innovative thinking.
• This is not an inclusive list of job responsibilities.
  
  

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 medical device regulatory experience is required.
• RAC designation is preferred.
• People Leadership experience including management direct reports and developing team members is required.
• Experience leading interactions and negotiating with global Health Authorities (i.e. U.S. FDA, EU Notified Bodies, etc.) is required, including leading and/or assisting with Health Authority audits.
• Expertise in developing and executing successful regulatory strategies for U.S. Class II devices and EU Class III devices is required.
• Working knowledge of IEC 60601 and 62304 is required, as well as, strong experience with standards management.
• Must have experience with global labeling requirements
• Experience with navigating regulatory compliance challenges (i.e. consent decree, field actions) is required.
• Must have FDA and Notified Body interaction experience
• Must have in depth knowledge of regulatory 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 experience with and have strong knowledge of regulatory submissions including 510(k) Notifications, De Novo submissions, and/or Pre-Market Approval applications.
• Must have demonstrated ability to mentor and develop a high performing staff.
• Computer skills must include comprehensive knowledge of all current and common computer tools (e.g. MS-Excel, MS-PowerPoint, MS-Word) as well as some specialized applications.
  
  

The base salary for the position is a minimum of $172,000 and maximum salary of $216,000 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. 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.