Regulatory Director for Combination Product
Vor 2 Tagen
**Job Overview**
The position of the Director Regulatory for Combination Product, Medical Devices and Emerging Technologies is based in the HQ of SHL Medical AG in Zug. It holds overall responsibility for Regulatory matters related to combination products, medical devices and emerging technologies. The holder is responsible for establishing applicable regulations in SHL entities. pertaining to all the markets currently being served by SHL on the assigned responsibility area. She/he is the lead regulatory affairs function for the respective regulatory affairs sites. He/ she and bears responsibility for the regulatory affairs activities, budget and personnel. Actively provides guidance to multiple departments and sites regarding Regulatory procedures and activities, including applicable Agency policies and regulations as well as regulatory affairs related customer relationships. Job holder is directly involved in the establishment of the product regulatory strategy and responsible for building regulatory services for SHL customer withing SHL responsibility and for the registration process including the entire product where needed and required by the customers. She/ He is owning the corporate procedures, submissions.
Follows up on regulatory affairs activities, like regulatory intelligence to ensure that the organization is adequately informed about new and current relevant standards, regulations, licenses and certifications.
**Duties and Responsibilities**
Individual Responsibilities:
- Strongly support CQRO to implement the Quality and Regulatory strategy and the decisions taken by the CEO and BoD.
- Responsible for the Regulatory Affairs function within SHL Medical ensuring product quality and reliability meeting and exceeding customer expectations for his area of responsibility.
- Advising customers on regulatory strategies within SHL responsibilities and for the entire combination product by building internal expertise for additional regulatory affairs services, where needed.
- Strategic adviser for product development team in building the right product strategy.
- Sets Regulatory Affairs objectives and ensure that targets are achieved for all regulatory affairs matters.
- Ensures that processes necessary for the regulatory affairs function are established, implemented and maintained according to national and international standards and legislation for his area of responsibility.
- Is responsible for evaluating the results of all regulatory affairs activities and for preparing recommendations for the CQRO about significant changes that need to be made to the organization in all regulatory affairs matters.
- Oversee the liaison with internal and external customers to ensure that the product documentation meets the organization’s standards, and that the organization provides best in class services for all regulatory affairs matters.
- Plans and coordinates with marketing, research, finance and other related departments on outlining registration component needs and timing. Interface with government on regulatory conditions for his area of responsibility.
- Responsible for developing and maintaining the network and information as well as providing reports on regulatory intelligence to SHL Medical quality systems.
- Provide effective leadership support, training, and mentorship for all regulatory affairs matters.
Leadership responsibilities:
- Shared for continuous improvements within area of responsibility to reach high quality standards and always look for innovation to meet current and future customer requirements.
- Responsible for standardizing and aligning the activities and processes of own department with other organizational units.
- Inspire cross-functional and cross-regional networking and knowledge exchange.
- Provides a system that supports the further career development of employees and ensures that the company can attract and retain the talented employees.
- Creates an environment that promotes great performance, inspirational leadership and positive morale.
**Minimum Requirements**
- Minimum of 10 years’ experience in Regulatory Affairs, Clinical Affairs and Quality Assurance.
- Proven expertise in regulatory affairs in a world-class combination products, medical device and pharmaceutical manufacturing organization.
- Extensive experience in managing Regulatory risk.
- Extensive experience in GMP and other Regulatory compliance requirements.
- Self Confidence and the ability to work with all levels of the organization.
- Operates in a way that never compromises ethics and integrity.
- Strong leadership skills.
- Ability to understand and adapt to different cultures and market need
**Preferred Qualifications**
- Extensive in regulatory filings for US, EU and other key countries/regions.
- German language is a plus
**We Offer**
- Modern working environment with state-of-the-art facilities and technologies
- Challenging assignments in a fast growing and innovative industry
- Position
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