Responsibilities

• Manage activities of Regulatory Affairs and prepare, review, edit and submit documents to the related authorities

• Develop, manage and implement operating documents, guidelines and common work practices | strategies

• Oversee and ensure compliance with regulatory procedures and work practices

• Manage the regulatory affairs team and ensure efficient operation of the function, including training, recruitment, performance management etc.

• Identify an optimal strategy for assigned projects and lead teams in examining regulatory strategy options

• Proactively identify new regulations and/or upcoming changes, and implement appropriate regulatory strategies accordingly

• Interface with (global) regulatory authorities & outside consultants and provide guidance to other regulatory personnel, plus provide regulatory advice to multidisciplinary teams as accountable

• Train, mentor and supervise the team members, consultants and contractors and develop the team as Manager of Regulatory Affairs ( x|f|m )

• Successfully completed Master's degree in a relevant scientific discipline, e.g. Biotechnology, Bioprocess Engineering, Chemistry or comparable

• Many years of experience at supervisory level in regulated environment e.g. medical device | biotechnology industry

• Competence and qualifications for the regulatory elements for medical device and ISO related certifications

• Experienced in managing a team providing active leadership whilst proven ability to work effectively and collaboratively in cross-functional and international teams

• Deep knowledge in interpretation of regulations, guidelines, policy statements, etc. and in interfacing with relevant regulatory authorities

• Expertise in the preparation of major regulatory submissions and understanding of applicable regulations

• Strong interpersonal skills and the ability to effectively dealing with a variety of personnel of different areas and hierarchies

• Strong organizational skills, including the ability to prioritize the own such as direct reports’ workload

• Business fluent in German and English (oral and written) as well as willingness to travel (approx. 10%)

• Strong i dentification with our core values: Sustainability, Openness, Enjoyment

What 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

• 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