Regulatory Affairs Specialist (m/f/d)Req # JR - 024704 Location Hechingen, Baden-Württemberg, Germany Job Category Regulatory Affairs Date posted 08/10/2020
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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.
Baxter offers a broad porfolio of vital renal and hospital products. These include acute dialysis as well as home and centre dialysis, sterile intravenous solutions, infusion systems and devices, cytostatics, parenteral nutrition, biomaterials for surgery and anaesthetics, as well as automation software and devices and services for the pharmacy.
At Gambro Dialysatoren GmbH, we are specialized in the development and produciton of innovative dialysators and dialysis chateters within the Baxter Group. Every day, around 1,300 highly qualified employees are committed to improving the quality of life of patients wiht kidney disease or renal failure.
In this role you will coordinate and execute regulatory activities for the entire life cycle of products.
You will be responsible for providing regulatory leadership or support for on-market products and new product development projects. In particular, this may include submission planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project sub-teams.
Duties and Responsibilities
- Compile and submit, in a timely manner, regulatory documents according to regulatory requirements and hands over to regional RA
- Provide regulatory advice to project teams
- Provide guidance and coaching for areas of responsibility to lower level team members.
- Maintain regulatory files (including CE Marking Technical File, STED, US submissions) in a format consistent with requirements
- Develops and implements complex regulatory project plans; Defines priorities together with the manager
- Manage regulatory activities relating to specific portfolio of products/projects (product owner)
- Maintain and update existing regulatory authorizations and licenses
- Lead or represent Regulatory Affairs in project teams
- Periodically reports about the status of ongoing registration activities under her/ his responsibility
- Provides follow up information during the review process of local health authorities; Coordinates registration activities with local RA and other parties such as sales, production and marketing
- Bachelor’s degree or country equivalent in engineering, pharmacy or related scientific discipline with a minimum of 5 years regulatory or equivalent experience within a medical device or pharmaceutical company, CRO, or similar organization
- Knowledge of international and European medical device regulation and international/European standards (ISO 13485, FDA regulations, MDD, MDR, MDSAP
- Scientific knowledge and ability to discuss technical matters with cross-functional team members
- Written and Verbal communication and strong negotiation skills
- Technical system skills (e.g. word processing, spreadsheets, databases, online research)
- Manage multiple projects, priorities and deadlines; in a matrixed environment
- Ability to identify compliance risks and escalate when necessary
- English and German fluently (written and spoken)
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.