Head of Regulatory Affairs

Head of Regulatory Affairs

My cleint is looking for a highly experienced, driven, Head of Regulatory. You will have a passion for detail and excellence, to help us execute world class manufacturing.

Reporting to the Chief Quality Assurance & Regulatory Affairs Officer, you will provide vision, leadership, support, collaboration and direction that ensures our systems and instruments are delivered to the highest standard. You will take a hands-on approach to leading the Regulatory function, working closely with the quality and manufacturing teams, and will have the skills to:

Implement the Regulatory strategy to achieve strategic operational goalsGuarantee the continual compliance of regulatory standards for products and processes to ensure reliability, consistency and safetyMonitor and report Key Performance Indicators across all areas of the regulatory functionCollaborate with other teams and functions across the business to drive best practise in the approach to regulatory.

Responsibilities;

• Working with the relevant business divisions to identify regulatory requirements for for my clients products
• Collaborating with all teams across the business to ensure all product meets the applicable regulatory requirements
• Representing my client in regulatory matters to influence outcomes and establish strong and valuable partnerships including communicating with regulatory and governmental agencies
• Overseeing the process of preparing product submissions to domestic and international regulatory bodies and leading the process from inception to approval
• Close collaboration with the Clinical team to ensure that patient safety is always maintained
• Leading and guiding the team to deal with complex negotiations with regional regulatory authorities
• Advising the business of any Regulatory changes/new requirements affecting my client, and medical devices, assessing their impact on the business and implementing changes where necessary
• Leading and supporting the team in the writing and editing of technical documents
• Leading research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
• Managing post market surveillance activities, complaints, field safety corrective actions, product recalls and medical device reporting of adverse incidents and evaluate to determine any regulatory actions required

Required skills and experience:

You'll have a thorough and sound working knowledge of regulatory compliance in Europe, USA, China and Japan, and a track record of successfully gaining regulatory approvals in various markets. We would also like you to have:

• Substantial senior medical device regulatory experience in multinational OR: Director-level experience for QARA in a smaller medical device company
• Leadership & management experience at senior level: coaching/mentoring/growing/shrinking teams; managing upwards & horizontally
• US FDA & CE marking experience for complex medical devices
• Post market surveillance experience in at least US or CE market for complex device
• Be an expert in medical device standards and regulations applicable in US and CE

In addition, you must have at least 2 of the following

• International regulatory experience (China, South Korea, Japan, Brazil)
• Sterile product experience
• Complex electro-mechanical experience, ideally Class III devices
• Software-heavy device experience
• Proven track record of driving up regulatory awareness within company through design, development, manufacturing
• MBA or similar qualification

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
We will contact you within the next 14 days if you are selected for interview. Privacy Policy. Equal Opportunity and Diversity Policy.