Adress Company presentation
The mandate at Global Brands Innovations and Sustainability (GBIS) / Product Safety, Clinical & Regulatory Affairs (SCR) at Essity is to enable success of our products in the market, based on high product safety standards, clinical evidence, and compliance with applicable regulations within our certified quality management systems. We think and act globally. We understand ourselves as business partners for our stakeholders throughout our products´ entire life cycles.
To enhance our readiness for new business and regulatory demands, we have created a team called "Global Regulatory Affairs & Product Safety Initiatives". The team serves as the first point of contact for topics which are new to SCR or affect multiple SCR teams.
Now, we are looking for someone that brings project management skills, drive, and cross-functional capabilities into the new position of Project Manager, Regulatory Affairs Initiatives. The position will report to the Global Regulatory Affairs & Product Safety Initiatives Director. The position can be based out of our offices in Gothenburg, Sweden or Hamburg, Germany.
We're looking for people who embody our values, aren't afraid to challenge, innovate, experiment, and move at a fast pace. We're always looking for ways to improve our products and ourselves.
If this is you, we'd love to talk.
Job description
In the role of Project Manager, Regulatory Affairs Initiatives, you will work with internal and external stakeholders for business-, assortment- or process-related topics which are either new to Product Safety, Clinical & Regulatory Affairs (SCR) and/or affect multiple SCR teams and/or the regulatory network.
The scope will further include SCR-overarching programs and projects to continuously ensure an effective and efficient base for safe and compliant products and solutions.
Your responsibilities will include:
* Manage projects and activities which affect multiple Product Safety, Clinical & Regulatory Affairs (SCR) teams / capabilities, e.g.
* for achieving UDI compliance globally,
* for efficiency across SCR and/or
* for ensuring one voice to our stakeholders
* Closely collaborate with Categories and Business Units for new business fields, by identifying their needs, proposing and bridging with ad hoc solutions until a permanent solution / accountability is put in place.
* Ensure regular monitoring and communication of changes in regulations, standards and guidelines affecting the market authorisation of our products.
* Prepare, coordinate and implement agreed elements of the SCR digital tools strategy.
* Support the global Regulatory Affairs network through information and best practice exchange.
* Coordinate and facilitate implementation of an SCR information hub for our internal stakeholders, such as training concept and SCR communication (Communication page, SharePoints)
* Actively participate in trade associations or other organisations for topics relevant to the position
What you need to succeed
You have at least 5 years of relevant professional experience in the regulatory / product safety compliance area of medical devices/cosmetics/biocides in an international environment. Not necessarily from working in an RA role, but working with such roles and environment (e.g. having worked in development of medical device products) and thereby having gained the necessary knowledge and experience.
You are self-driven, with an ability to engage others for a joint target. You have compelling communication and presentation, and have the ability to manoeuvre between a holistic view and a detailed level. You are flexible, and efficiently navigate and achieve results in a matrix organisation.
To succeed in the role of Project Manager, Regulatory Affairs Initiatives, you need:
* University degree in life science, natural science or law
* Minimum 5 years of relevant professional experience working with the regulatory / product
* Safety compliance area of medical devices, cosmetics and/or biocides gained in an international environment
* Proven track record of working and achieving results in a matrix organisation, with the ability to collaborate across diverse teams
* Proven track record of project management in the regulatory environment
* You are a self-motivated person with the ability to engage others for a joint target
* Compelling communication and presentation skills to different audiences with diverting interests, orally and in writing
* Good process understanding, but not dependent on process
* Ability to manoeuvre between a holistic view and a detailed level
* Fluent in English, any other relevant language is an advantage
What you get
You get to work cross-functionally, in a new global position that is still being formed, so you can be part of shaping the role.
At Essity, we believe everyone's learning and professional development is unique and want to empower employees to reach their full potential in a winning culture motivated by a powerful purpose.
* Collaborative and Inclusive Culture
* Empowering & Engaged Leaders
* Working with Powerful Purpose & Sustainable Impact
* Learning and Growing in your Career
* Supporting Well-being & Sustainable Working Life
* Life-changing Innovations
* Competitive Total rewards
Together, we are improving lives, every day.
Working at Essity is not just a career; it is a chance to directly make the world a healthier, more hygienic and safer place. With impactful innovations coupled with sustainable solutions, we strive to reach more people every year with the necessary and essential solutions for well-being.
What you need to do now
In this process, Essity cooperates with Hays. If you are interested in the role, apply directly. Do you have specific questions about the role? Contact the responsible recruiter Linus Norrbom at linus.norrbom@hays.com. We handle applications on an ongoing basis, so the position may be filled before the application deadline.
Welcome with your application!
