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Trabajos en Polonia de Directores de industrias manufactureras
Senior Director Regulatory Affairs
Clasificación del trabajo: Directores y gerentes › Directores y gerentes de producción y operaciones › Directores de industrias manufactureras, de minería, construcción y distribución › Directores de industrias manufactureras.
Traducción de la profesión: Kierownicy › Kierownicy do spraw produkcji i wyspecjalizowanych usług › Kierownicy w przemyśle przetwórczym, górnictwie, budownictwie i dystrybucji › Kierownicy w przemyśle przetwórczym.
Descripción de la oferta de trabajo:
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
#### Why join us?
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
Become a maker of possible with us!
Our vision for Regulatory Affairs at BD
The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric mindset.
#### About the role
As Senior Director, Regulatory Affairs you will lead the Regulatory Affairs function for the World Wide Infusion Preparation and Delivery (WWIPD) organization. This role is responsible for the development and execution of regulatory affairs strategy in support of the WWIPD strategic initiatives and encouraged to build and lead effective partnerships with regulators, including applicable Notified Bodies, US FDA, and key market regulators.
This position provides strategic expertise and leadership to its business partners, stakeholders (including Quality, R&D and Marketing) and direct reports to ensure functional excellence. The position is ultimately accountable for Design Controls new product design development programs and sustaining projects in alignment with business needs, driving timelines for submission/clearance targets, including EUMDR compliance, and Field Action Committee.
#### Main responsibilities will include:
Developing the regulatory strategic roadmap and providing regulatory leadership for programs in the pre-market and post-market space
Providing strategic mentorship to ensure alignment of regulatory strategies with business objectives and implementation of the strategic plans
Contributing to key strategic decisions impacting the development of global regulatory compliance policies, processes, and procedures
Building and defining regulatory pathways for new products - developing regulatory strategies and tactical plans for submissions regulatory bodies
Directs and contributes to the preparation and submission of U.S. [510(k)s, IDEs, and PMAs] and International regulatory filings for the business group products in accordance with policies and procedures established by the company and regulatory agencies
Directs the preparation of product information for product registrations
Incorporates Worldwide regulatory developments affecting the Business Group’s Platforms and Programs and communicates emerging opportunities and concerns to stakeholders
Leads a team of regulatory professionals responsible for product submission/registration activities, developing their skills and proficiencies, including regulatory knowledge and empowering them to interact and negotiate with regulators
Conducts training on regulatory issues for staff and for business stakeholders (e.g., Clinical, R&D., Marketing)
Represents the company in interactions with global regulatory agencies and Notified Bodies as well as external activities including trade associations, professional organizations, and standards development organizations
#### About you
We are looking for expert regulatory affairs professional with shown track of record in the medical device field (high-risk medical devices, pumping systems and/or software driven electromechanical devices) and strong leader with a minimum of 5-7 years of management experience.
#### You will also have:
* Ability to resolve problems and to make appropriate regulatory decisions
* Experience in negotiating with global regulatory agencies and Notified Bodies
* Shown success in the preparation and completion (including negotiations) of global regulatory submissions
* Extensive knowledge of:European quality system standards, and requirements under the medical device directive MDD 93/42/EEC required and EU MDS and US Food and Drug regulations and expertise in submission pathways
* Expertise in complex electromechanical medical devices including infusion pumps and consumables
* Excellent communications skills
* Strong project management and business acumen
* Shown leadership skills of multi-cultural, multi-national teams, leading and motivating associates towards the shared goals and the individual development
* Certifications such as RAC, PMP, and auditing certifications strongly preferred
B.S. or B.A. degree in a technical field (e.g., engineering, biology, chemistry)
* Click on apply if this sounds like you!
Becton, Dickinson and Company is an Equal
* Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
#### To learn more about BD visit: https://bd.com/careers
País del trabajo: Polonia.
Número de puestos: 1.
Empleador: Becton Dickinson Switzerland Global Holdings Sàrl.
Instrucciones para solicitar:
Forma de contacto:
- Teléfono: +48 50 865 41 10
- Sitio web: https://bdx.wd1.myworkdayjobs.com/EXTERNAL_CAREER_SITE_SWITZERLAND/job/CHE-Eysins---Business-Park-Terre-Bonne/Senior-Director-Regulatory-Affairs_R-480561
Oferta de trabajo obtenida del portal Eures, con fecha 17 de Marzo de 2024, y con identificador de la vacante:d89e6051-e1f1-11ee-ae92-a6afd4464b0f.
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