Cardinal Health Regulatory Affairs Lead EMEA (1 year contract) in Baar, Switzerland
The regulatory affairs Lead will manage regulatory activities associated with advertising and promotion of Cardinal Health product portfolio.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Management of EMEA regulatory activities associated with advertising and promotion of Cardinal Health product portfolio.
- Provide regulatory advice and guidance to commercial teams with respect to conference exhibit activities, disease awareness and speaker programs
- Review and approve EMEA product materials/communications to support company goals and comply with applicable laws, regulations, and guidance.
- Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, Legal and relevant process owners
- Monitor the external environment to advise teams on evolving regulatory requirements.
Provide input to key stakeholders with respect to process improvement for promotional review activities, including integration of additional businesses by coordinating with the global teams the implementation of new processes to support the new business.
Responsible for communicating business related issues or opportunities to next management level
- For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets
- Performs other duties assigned as needed
EDUCATION/TRAINING and/or EXPERIENCE:
- Bachelor’s Degree in Nursing, Engineering, Physical or Biological science or related field of study or related experience in the medical device industry; MS degree preferred
- Minimum 5 years of experience in the medical device industry in Regulatory Affairs
REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:
- Consistent background and knowledge of MD regulations
- Proven expertise in Regulatory Affairs, Law/Regulations, World Wide Regulatory Requirements/Procedures, Project Management, and Negotiations.
- Relations established with the key interlocutors in the network of the MDs (e.g., regulatory agencies, professional organizations, etc.)
- Ability to identify early the risks incurred by the company, to make the necessary warnings and propose appropriate action plans, in agreement with the QRA and Clinical Director.
- Ability to work in team and to share experiences
- Good communications skills, including English
ADDITIONAL POSITION REQUIREMENTS
- Travel: 15%-20% (predominantly to US HQ and regional offices)
- Occasional weekend/travel work may be required as necessary
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.