Project / Program Manager (m/f/d)
Permanent Employment, Full-time ・ München
Details
Your mission
Important notice: We believe that everything that belongs together comes together.
Therefore, we would like to kindly ask external recruiters and headhunters to refrain from making referral proposals.The
Project / Program Manager (m/f/d) is accountable for leading our cross functional team in the execution of multiple projects focused on the development of our drug delivery devices portfolio and our partnering programs for combination products.
Principal Responsibilities - Provide project and program management activities for one or more product development programs.
- Coordinate and drive development process planning activities including integrated development plans, budget inputs and go/no go criteria as appropriate.
- Work closely with the relevant management team to facilitate the elaboration, approval and execution of the global program and project strategy, as well as facilitate decision-making processes.
- Working independently, provide best in class operations and program management expertise to drive project team members towards excellence in execution.
- Maintain the overall development plans and enterprise portfolio inputs.
- Implement development plans by managing project teams, track project timelines and budget, drive team meetings/agendas/minutes including drive and track ‘actions’ and facilitate team goal setting and tracking to ensure adherence to plan and strategy.
- Issue and present reports to senior management on a routine basis.
- Help ensure consistent practices throughout all phases of the project life cycle.
- Applies best practices in the development, initiation, planning, execution, control and closing of projects.
- Interacts with all departments to ensure project information is reviewed and maintained.
- Contribute to developing the programme and project management processes used in the business, act as an advocate within the business for the agreed structured approach.
- Act as a key contact for PULMOTREE with external partners.
- Work effectively across cultural and scientific boundaries.
Your profile
- A University degree in a relevant subject or suitable experience in a device development
- Owns ideally a project management certification (i.e. IPMA)
- Experienced in the field of Inhalation (Nebulizer, MDI’s, DPIs) and respective combination products
- Experience facilitating/ leading multi-disciplinary teams
- Strong understanding and competency in planning processes and decision making.
- Demonstrated experience using standard program management tools and software including integrated development plans, timelines, risk management, and budget development and monitoring.
- Minimum of 5 years working experience, at least 2 years of that as a project manager / program manager.
- Proven track record of managing complex development projects in a highly regulated environment
- Knowledge in design control documentation and Quality by Design
- Experienced in Requirements Management (i.e. Requirements Traceability Matrix)
- Expertise in Risk Management, especially in project risks, dFMEA, pFMEA and patient risk analyses
- Knowledge in the usability of medical devices according to ISO 62366
- Self-motivated and “can do” attitude, a willing to be flexible, with an ability to adapt to change
- Excellent organisational and interpersonal skills and confident in building relationships and liaising at all levels, both internally and externally
- Very good communication skills both in German and English language
Please take into account that the place of work is Munich and an existing permanent work permit is required.
Why us?
We provide a creative nucleus, open to new ideas in medical product development and in the pharmaceutical industry.
In our young team, everyone can, and should, take on responsibility. In a dynamic environment, you can show what you can do and who you are because ability and character are more important to us than hierarchies and titles.
That means for example:
- Work in a professional and performance-oriented environment in international teams
- Freedom to develop your own ideas and drive them forward
- A fantastic team and a great place to work in our brand new Munich office
- Espresso, drinks, lunch allowance and other social benefits
- And of course an attractive salary
Apply now Regulatory Affairs Manager (m/f/d)
Permanent Employment, Full-time ・ München
Details
Your mission
The Regulatory Affairs managers provides regulatory affairs leadership across the business within a highly regulated medical devices and combination product environment. This role will be particularly responsible for:
• Implement and maintain regulatory affairs policies and procedures to ensure regulatory compliance
• Provide regulatory guidance to the development teams
• Preparation and submission of new products i.e. 510(k) or in declaring CE conformity
• Monitoring regulations, guidelines, and standards
Your profile
- A Diploma or Master degree in a relevant subject and/or suitable experience in a regulatory role
- Excellent knowledge of MDR, FDA requirements, with experience in supporting regulatory submissions
- Extensive knowledge of combination product requirements to support i.e. New Drug Applications (NDA)
- Regulatory requirements for medical devices, medical software, and combination products
- Experienced in risk management according to ISO 14971
- Proven track record of preparing and managing successful quality audits (internal/external) and inspections
- Very good communication skills both in German and English language
Please take into account that the place of work is Munich and a permanent work permit is required.
Why us?
We provide a creative nucleus, open to new ideas in medical product development and in the pharmaceutical industry. If we share the same values, then we should get to know each other.
In our young team, everyone can, and should, take on responsibility. In a dynamic environment, you can show what you can do and who you are because ability and character are more important to us than hierarchies and titles.
Apply now Unsolicited applications
Permanent Employment, Full-time ・ München
Details
Your mission
Haven't found a suitable position? Here you have the opportunity to have your application marked for future vacancies. Who knows, maybe you can even create a new position with your application, because your personality simply blows us away.
Your profile
In our young team, everyone can, and should, take on responsibility. In a dynamic environment, you can show what you can do and who you are because ability and character are more important to us than hierarchies and titles.
Apply now