Regulatory Affairs Product Lead
Our partner is a leading global operating company. They produce innovative products for the consumer market.
This position will provide strategic support to the company, lead a team of regulatory professionals and report to senior management. It is the responsibility of this role to ensure that the company's products comply with all relevant product-related legislation, mainly in the field of medical devices in the EU (European Medical Device Directives and Regulations, ISO13485, ISO14971 and other international / harmonized standards for medical equipment). The chosen person is expected to support and assist the company in any area of ??required regulation.
- Leading a team of regulatory professionals
- Report to senior management on project progress and regulatory issues for category products that may impact the direction or financial value of the wider organization
- Maintain a high level of regulatory expertise within the team (regulatory information, training, networking)
- Work as part of a multifunctional team by providing regulatory input for new product development, including artwork approvals, label claims, ads and associated supporting documentation
- Provide regulatory input for new product and brand strategies
- Analyze complex regulatory issues, including impact assessments of changes in regulatory requirements, develop implementation strategies and inform relevant stakeholders.
- Involvement in and supervision of the day-to-day management of the categories and management
- Ensure that product registrations, certifications and notifications are current and compliant
- Review and approval of technical files of medical devices in accordance with MDD 93/42 / EEC, MDR (EU) 2017/745
- Participate in central category and product meetings that represent the Regulatory Affairs function
- Ensure timely and effective communication and collaboration with other departments, including safety, quality, innovation, delivery and marketing
- Liaise with affiliates, respond to regulatory inquiries and provide notification / registration documents for the European territory as necessary
- Communicate with licensing, notified bodies, local and international regulatory authorities about license applications and compliance issues
- Contribution to development of category budget and Functional OGSM
- Collect data and write reports for projects / assignments as indicated by the Regulatory Affairs Director
- Master in a scientific or legal subject
- Fluent in English
- 10 years of relevant regulatory experience, with hands-on experience working with EU medical device legislation, background knowledge of all types of consumer health / over-the-counter products and experience in leading a team of regulatory professionals.
- Enthusiastic with the ability to communicate that enthusiasm to others
- Ability to handle pressure and work effectively in high pressure situations
- Flexible, agent of change
- The ability to work both autonomously and in teams
- Ability to prioritize decisions and activities to ensure resource efficiency and address critical issues affecting the business
- Excellent project management and organizational skills
- Excellent communicator
- Excellent problem solving skills.
- Passion for health products and compliance with regulations
- Strong entrepreneurial spirit, innovative and creative