Sr. Manager, Regulatory Affairs, CS

 

 

At Getinge we have the passion to perform

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.

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

 

 

Getinge is a global company that designs and manufactures medical devices and life science equipment. We impact the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are also engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels.

 

We are focused on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals who share this passion to join our team.

 

We currently have an opening for a Sr. Manager, Regulatory Affairs. This position 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 Surgery 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.
• 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.
• 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 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.

 

 

Required Knowledge, Skills, and Abilities

• 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 and Notified Body interaction experience; Must have strong knowledge of regulatory submissions including 510k notifications and pre-market approval applications.
• 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) is required.
• Expertise in developing and executing successful regulatory strategies for U.S. Class II devices and EU Class III devices is required.
• Must have in depth knowledge of regulatory requirements and experience with navigating regulatory compliance challenges (i.e. consent decree, field actions) is required
• Must demonstrate effective written and verbal communication skills, including technical writing skills.
• Computer skills must include comprehensive knowledge of all current and common computer tools (e.g. MS-Excel, MS-PowerPoi