VP Regulatory Affairs - Stuttgart - m/f/d
- Location: Stuttgart
- Salary: Negotiable
- Discipline: Medical Devices
The VP Quality Assurance and Regulatory Affairs will focus on domestic and international compliance for medical devices regulations globally including, but not limited to, EU MDR, FDA, TGA, ISO 13485: 2016, and MDSAP. You will lead complex regulatory and quality projects, provide regulatory review of labeling and marketing, design changes, new product introductions and specification changes for Class 1, Class 2 and Class 3 devices.
Functions and Responsibilities:
- Responsible for managing, initiating and maintaining all activities relating to domestic and international compliance for medical devices.
- Deliver strategies and perform activities necessary for global device registration in accordance with required directives and standards such as EU MDR (2017/745), ISO 13485:2016, FDA (510(k)s), cGMP, Medical Device Single Audit Program (MDSAP).
- Participate on Product Development teams to provide regulatory and quality strategies, timelines and direction.
- Manage, update and enhance QMS activities and documents to meet compliance needs.
- Conduct trainings on appropriate regulatory materials and policies as needed to enhance personnel knowledge of working in a regulated environment.
- Develop and maintain regulatory and quality department global procedures.
- Perform regular assessments and audits of facilities and critical suppliers.
- Work with R&D to prepare, submit and maintain Technical Files for global compliance.
- Submit, lead and facilitate product and facility registrations, design change notifications and applicable renewals as required.
- Provide responses to governmental requirement queries and documentation requirements.
- Oversees all risk management activities to ensure compliance
- Oversees government compliance audits and directs CAPA activities for findings and improvement actions to ensure on-going compliance.
- Develop and manage strategies for compliance with device/document labeling, symbols and testing for EMC/Safety requirements and other market entry requirements.
- Submit and maintain database information for UDI, EUDAMED and GUIDID as required.
- Manage PMS, Complaints and all reporting/surveillance and field correction activities.
- Maintain knowledge of new, revised regulations and guidelines.
- Serves on Global Quality Board and Global Regulatory Board as well as other committees as applicable.
- Performs special projects as required by executive management.
- Minimum 7 years International Regulatory experience with Medical Devices
- Bachelor's Degree (Masters Preferred)
- In-depth knowledge and proven experience with EU MDR (2017/745), FDA, ISO 13485:2016 and MDSAP submissions - at a minimum.
- Demonstrated understanding of advanced technical principles related to regulated environments and harmonized standards.
- Native German and Fluent English
- Hands-on, results oriented with ability to implement actions effectively.
- Strong and organized leader with a positive attitude.
- Ability to work both independently and with cross-functioning departments/teams.
- Understanding of the need to balance quality with efficiency and good business sense.
- Provide knowledge based solutions.
- Manage multiple complex projects under pressure with demanding deadlines.
- Ability to handle frequent travel both domestic and international