Pms and Vigilance Specialist

For our Regulatory Affairs Pharma & Systems department within Sartorius Stedim Biotech GmbH we are currently looking for a PMS and Vigilance Specialist (x|f|m) at our headquarters in Goettingen (full-time, with the possibility to work some days remotely). The overall goal for the owner of this role will be to assists the Bioprocess Solutions (BPS) business with fulfilling the Post Market Surveillance and Vigilance tasks defined by the regulatory and internal requirements, related to the BPS core product portfolio (including Medical Devices, IVDs, devices for Food & Beverage as well as Pharmaceutical & Life Science industry). **Grow**with**us** -**Your**Responsibilities** - Conduct and assist the PMS, PMCF, Vigilance and Recalls (FSCAs) processes according to our processes and documented procedures (as process owner) - Further coordinate PMS data gathering and prepare the PMS plans and reports (PSURs), including review & signoff of the documents - The more, coordinate the outsourced PMCF activities and communicate with the external PMCF Service Provider - Organize PMCF data gathering and internal document reviews for PMCF data and reports, including signoff of the documents as PMS and Vigilance Specialist (x|f|m) - Drive the recall process by organizing meetings, creating decision trees, and evaluating potential recalls (FSCAs) and | or reportability of incidents and complaints plus communicate these cases to authorities - Responsible for internal and external audits related to PMS, PMCF, Vigilance and Recall topics - Review and revise the documented procedures and related documentation for PMS, PMCF, Vigilance and Recalls (FSCAs) as part of process ownership - Collaborate with the R&D, Product Management, Quality Assurance and Sales and Marketing Departments to ensure regulatory compliance **What** will**convince**us** - Successfully completed Master’s degree in Life Science, Biotechnology, Pharmaceutics, or in a comparable scientific field - Several years of experience within the regulatory affairs discipline in a manufacturing environment, experience in pharma or medical device industry - Deep knowledge of regulatory requirements for devices | products in the above listed areas and that of electronic data management systems - Ability to develop innovative strategies and creative solutions within the regulatory context - Proven analytical skills and technical competence meet strong initiation and organizational skills - Attention to detail, ability to appropriately assess risks and proactive, quick learner such as independent worker - Excellent communication skills, with ability to influence and negotiate a successful outcome under global matrix environment - Fluent in English, German will be a plus - Identification with our values: Sustainability, Openness & Enjoyment **What**we**offer** As a growing global life science company, stock listed on the DAX and TecDAX, Sartorius offers a wide range of Benefits: - ** Personal and Professional Development**:Mentoring, leadership programs, Talent Talks, internal seminar offerings, coaching for managers - ** Work life balance**:Remote options, flextime, flexible work schedules, sabbaticals - ** Attractive compensation**:Vacation and holiday bonuses including pension benefits with a 35 hr. week, 30 vacation days - ** Large, modern campus**:Open office spaces, terraces, company restaurant with vegetarian and vegan options, cozy Italian bistro with ice cream sales, fitness studio and daycare center - ** Making an impact right from the start**:Comprehensive onboarding, including a virtual online platform even before joining, Welcome Workshops, "buddy" as point of contact - ** Travel benefits**:Car leasing, bike leasing, large free parking garage, good bus connections - ** Welcoming Culture**:Mutual support, teamspirit and international collaboration; communities on numerous topics, such as coaching, agile working and business women network