Group Lead Regulatory and Compliance MCC

In this role you have the opportunity to
lead a team of 8 Safety & Compliance Managers and Regulatory specialists and be the primary point of contact for and spokesperson towards the business partners and in the country organizations for all Mother & Child Care products developed in the Innovation Site in Eindhoven the Netherlands and PIC Shenzhen in China. The SCR team lead MCC to ensure that the products offered for approbation and registration meet all the requirements in order to bring consumer products and medical products to the market complying with Philips policies Safety standards and worldwide Regulations in a competitive environment.

You are responsible for

• Ensures all products meet regulatory standards and compliance requirements by coordinating and managing regulatory submissions registrations and approvals ensuring thorough documentation and adherence to all relevant guidelines and standards.
• Manages and guides the regulatory compliance team establishing a competence matrix and ensuring the team effectively handles PDLM/MLD projects to maintain high regulatory standards and performance efficiency.
• Conducts thorough risk assessments for regulatory compliance and implements corrective actions to address any identified issues rejecting or escalating applications when they pose risks that cannot be resolved locally mitigating potential risks and ensuring continual compliance with regulatory standards.
• Monitors and influences regulatory and legislative changes advocating for favorable policies and ensuring the companys interests are represented staying ahead of industry trends and adjusting strategies accordingly.
• Provides strategic advice and guidance to product development teams on regulatory requirements influencing product design and expedites regulatory approvals for products in controllable situations to reduce time to market while ensuring all compliance requirements are met.
• Oversees the preparation review and submission of regulatory documentation to ensure accuracy and completeness maintaining records in compliance with regulatory standards and facilitating smooth regulatory reviews and approvals.
• Develops and delivers training programs to enhance the regulatory knowledge and awareness of internal teams ensuring a culture of compliance throughout the organization and equipping staff with the latest regulatory insights and practices.
• Coordinates the development and execution of global regulatory strategies including CE Marking clinical evaluations and product registrations ensuring successful market entry and compliance across regions and managing cross-functional collaboration.
• Engages in frequent interactions with senior management or executive levels regarding matters spanning multiple functional areas divisions and/or customers providing expert insights and influencing strategic decisions.
• Establishes and ensures adherence to budgets schedules work plans and performance requirements to maintain operational efficiency and effectiveness optimizing resource allocation and project timelines.
• Offers strategic guidance on understanding and implementing standards and regulations consults with product teams on transitioning to new requirements and represents the organisation on technical committees to influence the development of industry standards.
• Manages talent across the team driving employee selection performance management compensation management and career development ensuring effective operational management and fostering a high-performing regulatory team.

You are a part of

directly report to the Business Unit Safety Quality and Regulatory Lead MCC. This role to ensure implementation for the business categories. The SCR team you will work with and are part of is diverse and international with teams located at all development sites around the world andcounterparts in the markets.

To succeed in this role you should have the following skills and experience

• Minimum 5 years of experience with Bachelors OR Minimum 3 years of experience with Masters in areas such as Regulatory Affairs in Medical Devices Industry or equivalent.
• Extensive knowledge on (non-)Medical Device development standards (e.g. ISO13485) and regulations (e.g. 21CFR820 EU MDR) and FDA 510K
• Extensive experience with Design and Development Safety and Compliance standards
• Proven track record in global approbation and registration activities of Non Medical and Medical Devices
• Team management experience
• Demonstrated strong collaboration across cross-functional teams with proven leadership skills consistently driving results
• Committed to transformation proactive for fresh perspectives and focused on efficient execution.
• Strong analytical skills and structured way of working
• Affinity with Mother & Child Care products

How we work together
We believe that we are better together than apart. For this role it means working in-person at least 3 days per week.

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