Responsibilities

Quality

• Develop and maintain our quality system as the company scales in size.
• Ensure that quality records and technical documentation remains up to date
• Pass yearly surveillance audits with notified body with the goal to maintain our certification
• Work across departments to ensure process compliance and appropriate documentation

Regulatory

• Work with executive team to determine corporate goals and develop regulatory strategies to support corporate goals.
• Execute regulatory strategies (creation and submission of required documentation)
• Interface with regulatory bodies on all relevant topics (e.g. to obtain feedback on regulatory pathway and on approval/clearance requirements)
• Network within the regulatory field

Other

• Manage a network of consultancy firms for specialized advice
• Additional regulatory or legal work such as clinical trial submissions, ethics approval, patents, trademarks and others
• Build and manage the regulatory department

Requirements

• At least 7 years of experience with regulatory affairs & quality management systems. Ideally within the field of contraception, mobile applications or digital health.
• Outstanding knowledge of FDA Quality System Regulation 21 CFR 820 (US), ISO 13485 Medical devices Quality management as well as IEC 62304 for software development and the directive 93/42/EEC for medical devices. Experience from working with medical devices of class II or III in EU and US is required.
• You can translate and communicate the requirements to other members of the company in order to develop efficient processes and documentation.
• Experience with managing a small team and efficiently making use of consultants.
• You are service-minded, solution-oriented and effective.
• You are passionate about regulatory affairs, compliance and achieving market access.