Sr. Manager, Regulatory Affairs

 

 

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 Endovascular 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 Pre-Market Approval applications (including Supplements, Amendments, and Annual Reports), IDEs, 510(k)s, Technical Documentation and other applicable country regulatory submissions and requirements.  This position will be primarily responsible for Getinge’s Class III balloon-expandable covered stent product portfolio and will have responsibility to manage and develop the regulatory department staff supporting these products (two direct reports).

 

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 Endovascular 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 Endovascular 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.
• Main point of contact for regulatory authorities, managing all communication, including pre-submissions and meetings with regulatory bodies.
• 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 meeting techniques and preparation.
• Encourage and lead others 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.
• Monitors compliance with company policies and regulatory procedures consistent with EU and FDA.
• This position interacts directly with both external and internal auditors as the Subject Matter expert to ensure that the company’s global change control process maintains compliance to internal and external regulations.
• Assists in special projects as needed.

 

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