Head of Regulatory and Quality - Bioelectronics

Basic qualifications: 

• Extensive experience and intimate knowledge of regulatory submissions for Class III/active implantable medical devices 
• Experience in providing oversight for quality assurance for Class III/active implantable medical devices
• Track record providing quality and regulatory guidance across functions 
• Track record of successful interactions with regulatory bodies

Preferred qualifications: 

• Prior regulatory experience in both the US and EU with implantable neuromodulation devices, including both strategy setting and execution for early clinical feasibility testing and marketing approval
• Prior regulatory experience with the development of therapies for chronic diseases, including experience from pharmaceuticals or biotech companies
• Leadership role in successful IDE and PMA submissions (and the equivalent in non-US geographies)
• Regulatory affairs certification
• Leadership role for the overall design and implementation oversight of Quality Management Systems
• Executive-level entrepreneurial and line management track record

Details: 

** This role will be located in South San Francisco, California US or Stevenage UK or - Relocation support will be provided if required **

Summary ...

As the Director and Head of Quality and Regulatory you will lead the regulatory affairs and quality assurance for Galvani Bioelectronics. As  member of the Galvani executive management team, you will play a pivotal role in realising the potential of bioelectronics medicines, developing and implementing strategies that will bring the company’s transformational therapies both safely and rapidly to patients globally. You will develop the company’s regulatory strategy for programs across multiple major chronic diseases, including early and active partnering with regulators globally on the clinical feasibility and market approval evidence path for this emerging class of therapies. 

You will also, through your oversight of the quality assurance function and together with a quality manager reporting to you, guide scientific, engineering, and project teams across the company as well as its network of partners, ensuring successful design, roll-out and reliable use of quality systems and processes. 

Your accountability will span regulatory strategy setting and quality management in pre-clinical work and device prototyping, oversight of verification and validation of neuromodulation systems to meet clinical trial requirements, preparation of multiple files for clinical feasibility studies, and all the way through to delivering timely and successful submissions for marketing approval globally and across multiple diseases.

Key Responsibilities ...

• Deliver successful regulatory strategies and submissions 
  - Develop and implement comprehensive regulatory strategies for neuromodulation therapies
  - Represent the company, driving meetings with global regulators with an initial focus on FDA and European authorities
  - Guide scientific, clinical research, marketing and commercial staff within and outside Company to ensure compliance
  - Orchestrate the preparation of compliant regulatory filings
  - Formulate company responses regulatory authority queries

• Take overall accountability for effective quality assurance  
  - Oversee the design and roll out of the quality management system to ensure correct, and efficient capture throughput of essential documentation
  - Guide the Quality Manager in him/her
     * performing annual and random audits of suppliers and analytical laboratory, etc., both internally and externally
     * partnering on the development of methods to characterize and test prototypes and products according to regulatory standards
     *  assessing and approving specifications, sampling instructions, test methods, validation protocols, validation reports and other QC procedures
     * ensuring the appropriate validations are completed

• Assembling a strong Regulatory and Quality team
  - Provide organizational leadership for worldwide regulatory and quality professionals, including a Quality Manager that will be hired imminently 
 - Take budgetary responsibility and identifies appropriate external resource as needed


*LI-GSK

When applying for this role, please use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter will be used to assess your application.

Thank you for your interest in this opportunity.

Contact information: 

You may apply for this position online by selecting the Apply now button.