We are looking to assemble a team of best-in-class, innovative and passionate people. We want to gather their talents and skills to achieve one goal: unlock the power of “DNA-write”. We offer the opportunity of joining a dynamic, international, and highly skilled team in a pioneering startup. Our Next-Hour DNA Synthesis platforms not only have the potential to change the way the world makes and uses synthetic DNA, but also to accelerate the rate of discovery by delivering upon the promise of same-day results.

DNA Script is actively searching for a Quality and Regulatory Affair Director who will report directly to the CEO and be responsible of the creation and the management of all activities related to quality and regulatory. You will define procedures, advise operational departments, and guarantee the regulatory and quality compliance of products at each stage of their development, from concept to delivery.
In this context, you work closely with the various departments of the company (R&D, Product Development, Manufacturing, Marketing, Sales, Management) and the service providers.

Responsibilities

Strategy and build-up of activity

• Build-up the Regulatory and Quality team and activities;
• Create and maintain quality procedures, documentation and processes for the Company to operate at gold standard from industry stand-point;
• Lead and be responsible for product certification in different regulatory frame-work and regions, in-line with Company strategy and objectives;
• Lead the team in place (one engineer) to complete projects according to established timelines and needs, and develop the team in France and in the US;
• Have a comprehensive knowledge of the product and its life cycle to analyze product characteristics and to review processes, objectives and constraints within each department;
• Identify and analyze the regulatory framework and the modalities of introduction to the European and US markets for the product. Study the ISO 9001 and ISO 13485 certifications applicable in the company, as well as the internal quality objectives required by the Management team;
• Define, propose and put in place the Regulatory and Quality strategy to the Management team for current and new product projects, by developing several iterations taking into account the risks and trends.

Quality

• Define and implement the QMS system and software;
• Create quality control tools and develop procedures;
• Provide guidance and train each department to the quality rules and procedures;
• Analyze performance indicators and manage incidents;
• Manage audits and relations with certifying organisms;
• Be responsible for identifying impacts of international regulations, standards and guidance to our Quality Management System.

Regulatory Affairs

• Propose and lead a strategy regarding regulatory frame work, Company and product certification;
• Provide guidance and training to explain the objectives of the regulatory provisions and define the procedures within the departments;
• Control the respect of protocols;
• Collect from the departments the information and technical documentation necessary for the preparation of registration, authorization or declaration files, as well as for CE marking. Lead preparatory meetings;
• Lead and be responsible for all the certification process, relation with certification bodies and fillings;
• Ensure that authorizations are obtained within the regulatory deadlines and those required by the sales objectives;
• Control compliance (finished product, documentation, communication). Authorize the launching of batches;
• Carry out studies and manage audits with service providers.

Qualifications and experience

Essential

• Masters’ Degree in Medical/Biotech Engineering, Pharmacy or equivalent,
• At least 8 years of experience in Regulatory Affairs and Quality Assurance environment, preferably with background in Biological Sciences,
• Experience in the build-up of a Regulatory and Quality department,
• Demonstrated management or supervisory experience with strong interpersonal and influencing skills,
• Experience in ISO certifications (ISO 13485, ISO 9001, etc.) and CE marking,
• Experience in medical device or Life science tool,
• Excellent written and oral communication skills with a strong emphasis on organizational capabilities and external communications,
• Demonstrated flexibility and adaptability in carrying out various assignments in a concrete way,
• Operational and concrete problem-solving mindset,
• Excellent written and verbal communication skills,
• Strong organization and analysis/problem skills,
• Strong attention to detail/quality focus,
• Familiarity with Quality concepts and practices,
• An in-depth knowledge of European and International regulations,
• Fluent in English.

Desirable

• Start-up mind-set is strongly preferred,
• Understanding of the product introduction,
• Experience in GMP.

• Phone interview with manager
• Day interview with manager, cofounders, HR and the team
• References check
• Timing: around 2-3 weeks