- Od 250 do 2000 zamestnancov
Project Manager Regulatory Affairs/Public Affairs (Temp)
- Zmluva na dobu neurčitú
- Vzdelanie: 3-ročné vysokoškolské štúdium
- skúsenosti: > 3 roky
Who are they?
Edwards Lifesciences is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. They are driven by a passion for patients, dedicated to improving, enhancing and saving their lives.
There are more than 300 employees in the Prague business center, and more than 14,000 globally. The Edwards Prague office has a broad range of regional and global roles. The employee population in the Prague office is very diverse with more than 30 nationalities represented, therefore, English is the language spoken by all.
Joining Edwards means innovating, pushing boundaries and being creative while always putting patients first. It means solving challenges with colleagues who share a sense of urgency, optimism, and enthusiasm, colleagues who are focused on testing their limits and taking ownership. And it means that employees are empowered to get the job done by taking charge of their work, health and career.
We are looking for Regulatory Affairs Project Manager to manage a large projects involving European medical device regulations. This person will be responsible for project governance and manage all implementation for multiple projects related to MDD to MDR Transformation, Brexit/SwissExit. ECRep changes and similar. This candidate will need to manage submissions for regulatory filings and preferably comes from a long term regulatory background within medical device / life-sciences / pharma.
- Determines and discerns detailed requirements on larger scale projects to establish the project deliverables, and manages changes to the project scope, schedule, and costs to keep the project management plan updated and reflective of authorized project changes
- Facilitates the creation and approval of business cases, and utilizes historical data and expert judgment in order to understand project limitations
- Establishes and maintains team members and project stakeholder relationships, expectations, and communications
- Measures project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify variances, perform required corrective actions, and communicate to all stakeholders
- Executes and leads the execution of tasks as defined in the project management plan in order to achieve the project goals, and actively manages project risk
- Manages project closure activities, including gathering lessons learned
- Serves as a project management subject matter expert, including guiding and mentoring other project managers; demonstrates expertise in a business process, professional discipline, market, or product
- Actively leads one or more Project Management Office (PMO) continuous improvement activities
- Other incidental duties
What is it like to work at Edwards Lifesciences?
As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.
We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the EdwardsNetwork of Women, Edwards Foundation charity team, sustainability activities, and others).
Edwards Lifesciences in Spain also offers the following benefits:
- Competitive Compensation and Benefits package
- Flexible working hours, remote working
- Pension plan
- Life Insurance
- Medical plan
- Meal Vouchers
- Service Awards
- Enhanced Leave benefits
- Employee Stock Purchase Programme
- Employee Assistance Programme
- ComprehensiveWellness programme including gym membership reimbursement, fresh fruit in theoffice, yoga lessons, subsidized massages, mindfulness sessions, educational events, charity activities and much more.
Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefits policy and components may vary by location.
Desired Skills and Experience:
- 3-5 years of project management experience within a regulated industry (Pharma/Med Tech).
- Experience managing regulatory bodies, CE Mark, FDA, MDD/MDR, Brexit.
- Medical Device / Life Sciences / Pharmaceutical industry experience
- Bachelors Degree
- Masters Degree
- Supply chain and labeling experience (labeling, eIFUs, submissions, etc.)
- Proven expertise in usage of MS Office Suite and related project management systems
- Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
- Extensive understanding and knowledge of principles, theories, and concepts relevant to managing large scale project plans
- Excellent problem-solving, organizational, analytical and critical thinking skills
- Excellent understanding and work experience with project budgets and financial management
- Strong leadership skills and ability to influence change
- Experience in facilitating change, including collaboration with management and executive stakeholders
- Experience within a regulated environment
- Strict attention to detail
- Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including serving as consultant to management
- Ability to interact with suppliers, vendors and/or customers
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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