JOB DESCRIPTION:

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).

Responsibilities:

• 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.

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 10 years medical device regulatory experience is required.
• RAC designation is preferred.
• People Leadership experience including management direct reports and developing team members is preferred.
• Experience leading interactions and negotiating with global Health Authorities (i.e. U.S. FDA, EU Notified Bodies) is required, including leading and/or assisting with Health Authority audits.
• Expertise in developing and executing successful regulatory strategies for U.S. Class III PMA devices and EU Class III devices is required.
• Experience with navigating regulatory compliance challenges (i.e. consent decree, field actions) is required.
• Understands the requirements of FDA 21CFR Part 820, EU MDR, MDSAP, CMDR and ISO 13485 and strong experience with standards management.

Skills & Abilities:

• Must have FDA and Notified Body interaction experience.
• Must have in depth knowledge of regulatory requirements.
• Must have experience with global labelling 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 Pre-Market Approval applications (PMA) and 510(k) Notifications. Additional experience with IDE and De Novo submissions is a plus.
• Must have demonstrated ability to mentor and develop a high performing staff.
• Team player who can communicate and collaborate proactively with all staff members to achieve corporate and project goals.
• Must be detail oriented and possess excellent organizational skills with a demonstrated ability to manage multiple projects with strict deadlines.
• 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.

• 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