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 VP of Regulatory Affairs for our global Acute Care Therapy business area. This position will provide strategic guidance and domain expertise to deliver industry best-in-class leadership and influence the regulatory direction of the company. Key points of accountability will be leadership and oversight of external regulations, execution of policies impacting patient safety as well as management of submissions and registrations. This position will also provide crucial leadership of managing key regulatory agency interactions.

Job Responsibilities:

• RA Leadership – Provide strategic leadership and vision for ACT’s Regulatory function and determine key RA objectives linked to ACT strategy. Drive implementation of RA strategy while keeping with the global regulatory environment
• Apprise the Executive leadership of ongoing status of compliance and regulatory and making recommendations for areas requiring further attention. Influence executive decision-making regarding prioritization of all projects to obtain critical resources and funding for projects.
• RA Organization – Help define and develop a robust RA organization that supports ACT goals and objectives and delivers to the strategic roadmap of the organization. identify and evaluate critical positions within the function and establish strategies to develop strong talent pipelines and robust succession plans
• Provide regulatory leadership, training and vision by interpreting regulatory affairs initiative and mandates, uncovering emerging trends and providing the processes necessary to meet rising expectations. Assist in the training of ACT employees with regard to global regulatory requirements, policies and procedures.
• RA Submissions – Develop and implement strategies for new product licensing, maintaining license on existing product portfolio in all markets of operation. Follow and understand the development of global regulatory strategies, and timelines for product development projects, working to ensure that various pathways are examined early in the process, potential issues brought to the attention of the team early, and backup plans in place in order to keep product registration and commercialization on track.
• Authority Relationship Management - Develop and manage direct and indirect relationships/interface with the regulatory agencies in the various key markets (United States, Europe, China, India, Australia etc.). Represent the Company with outside entities such as regulatory authorities, government entities and industry trade associations for driving key initiatives and compliance solutions
• Compliance Support – Support and collaborate with Product Areas and ACT Quality and Corporate Quality in managing compliance challenges in the ACT Business Area. Develop effective strategies and solutions including communication cadence with authorities for driving compliance in the Regulatory organization.
• Lead collaboration with corporate, divisional and regional partners in development of effective strategies, protocols, goals, standards and tools that ensure compliance and improve functional and cross-functional efficiency, effectiveness and communication in respective domains. Oversee execution of these strategies; adjust and collaborate to ensure mutual success.
• Regulatory Intelligence – Represent ACT RA in the corporate QRCM organization and collaborate with corporate RA on Regulatory intelligence. This role will be accountable for implementing the actions coming from Regulatory Intelligence into the ACT BA. Act as independent subject matter expert in giving guidance to divisions, while considering business implications. Support and advise product areas on requirements for acquisition integration and new product development.
• In- Country Regulatory compliance – Ensure license to operate in all markets. Develop and support robust re-registration strategies for RA teams in the PAs and PAs are accountable for delivering work products to the In-country RA teams who will do the actual registration. This position will have to design and implement a framework that enables efficient and effective interaction and achieve end result ensuring live certificates

Qualifications

• Minimum of 15 years of direct Regulatory Affairs experience; Bachelor degree or equivalent years of experience in science or relevant technology or Regulatory management
• Minimum of 10 years of direct management experience leading global Regulatory teams
• Expertise in Regulatory pathways including PMA, 510(k), EU MDR, and International registrations
• Experience in direct interaction/established relationships with global regulators
• Proven experience in developing Regulatory strategies, ensuring effective implementation across the organization, including converting the strategies to meaningful and motivating goals & objectives
• Ability to manage complex matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization

About us

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. Our passionate people hold our brand promise ‘Passion for Life’ close to heart.

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted MedTec company.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

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.