Director of Quality & Regulatory Affairs, Natus Medical Denmark / 1624
On behalf of Natus Medical Denmark A/S (formerly GN Otometrics) Best Talent is searching for a strong, energetic and quality-oriented QA/RA leader.
Would you like to be part of a dynamic international company in transformation, where you can influence your own position and the company’s processes? Do you want to contribute to developing a highly effective QA/RA function, which supports the company in satisfying customer requirements and in achieving excellent results? Then come join an industry leader, providing medical solutions that make a difference to people around the world.
Since the company is growing rapidly, we are seeking a Director of Quality & Regulatory Affairs who will have a key role in redefining the QA/RA department and be the link between Global QA/RA and other functions – R&D, Sales and Marketing, Production and Supply Chain.
The Director of QA/RA will work closely together with the cross-functional management team and functional departments. Through optimizing processes and securing compliance and conformity with relevant regulative directives and standards, the Director of QA/RA will support the development and improvement of business results.
The Natus Medical Denmark QA/RA department consists of a team of 14 dedicated colleagues located at our headquarters in Taastrup and our branch in China. The company is well established and is now looking for a skilled Director of QA/RA to secure all processes for Quality Management system are established, implemented and maintained.
As the new Director of QA/RA, you will be responsible for providing initiatives improving an effective quality function. You are responsible for aligning processes and priorities according to the plan. You are able to think strategically and enjoy acting operationally. You communicate precisely on all levels to ensure that the processes, approvals and certifications related to quality are followed. You will develop and maintain the QA/RA function to reflect customer demands and interface with FDA, notified bodies and other regulatory authorities.
You will provide leadership for 14 dedicated people. Therefore, you need to manage, motivate and develop the QA/RA function globally, ensuring high performance and value creation within the teams. You do that by allocating and managing the resources in regards to the daily operations, ad hoc type tasks and development of the function.
Your tasks will be:
1. Responsible for strategic planning, staffing and budgeting of QA/RA department activities and programs. Participate as member of strategic business unit management team.
2. Responsible for regulatory compliance with U.S., Canada and the EU requirements (FDA CFR, CMDR, ISO 13485 and MDD). Interface with FDA, notified bodies and other regulatory authorities to ensure compliance with worldwide regulations. Responsible for the development, preparation, submission and maintenance of FDA 510(k) submissions, EU Technical Files, Health Canada licensing and other global product registrations.
3. Manage and develop team of quality and regulatory professionals. Provide appropriate mentoring, appraisals and discipline of direct reports. Ensure that all direct reports are familiar with, trained on and follow all Quality System procedures related to their jobs and that changes to procedures are reviewed, approved and validated prior to implementation.
4. Implement corporate QA/RA objectives and procedures. Set QA/RA goals and objectives for business unit, individual facilities and direct reports. Ensure that resources and activities are aligned with site, business unit and corporate objectives.
Natus Medical Denmark (formerly GN Otometrics) offers you a challenging opportunity where you will be able to put your mark on the job in a dedicated, fun and international environment. You will be given the chance to work with dedicated people, based on value-based management, which provides every employee with responsibility and opportunities for development. You will be part of the management team of Natus Medical Denmark A/S and report directly to the Global VP, QA/RA of Natus Medical Incorporated.
The preferred candidate will possess the following profile:
• You have a relevant education and proven results as a strong leader
• Experience managing Quality Systems is required also with US CFR quality systems regulations
• You have +8 years of experience preferably from a position with direct responsibility for QA/RA/production from the Medical Device industry
• You are used to interface with international NB and have good skills within standards and regulations as MDD, FDA, Documentation, Files and CE marking. Knowledge of FDA 510K clearances and technical file audits is recommended
• Proven ability to grow and thrive in a dynamic environment such as a US-based company
• Ability to effetely present information to top management, public groups and boards of directors
• You are fluent in English and wish to be an excellent communicator to influence in a global organization
The right candidate will have a proven leadership record of accomplishment with several years of experience as a QA/RA Director.
As a person, you have a positive attitude, are committed and strive for results. It is important that you are focused, can prioritize and keep calm when deadlines are tight. This process requires that you are able to adapt to different situations with short and sometimes conflicting deadlines. You like to navigate through multiple levels of complexity in quality and regulatory requirements, procedures & systems in a large organizational structure.
You are competent in decision-making and execution and are able to bring the QA/RA function to the next level. You manage to drive projects in a good manner and at the same time motivate people around you to do their best. In other words, you have a desire to support and enrich Natus Medical Denmark’s culture.
Best Talent is responsible for your employment at Natus Medical Denmark A/S and will review your application on a confidential basis. Forward your application including your CV marked ”1624/Director of QA/RA” by way of e-mail to email@example.com. You can read more about Best Talent on www.besttalent.dk.
Natus Medical Denmark A/S (formerly GN Otometrics) is the audiology industry leader providing instrumentation and software solutions to hearing and balance care professionals worldwide. For more than 50 years, Natus Medical Denmark A/S has been helping hearing and balance care professionals succeed in improving the quality of life for their clients and patients around the world by delivering expert knowledge, reliable solutions and services – providing a trusted partnership.
Natus Medical Denmark A/S develops, manufactures and markets computer-based audiological, otoneurologic and vestibular instrumentation in more than 80 countries under the Otometrics brands, including MADSEN®, AURICAL®, HORTMANN®, ICS® and Oscilla. Natus Medical Denmark A/S is part of Natus Medical Incorporated (North America NASDAQ: BABY) – a US-based leading provider of healthcare products, devices and services used in the newborn, neurology, sleep, hearing and balance markets. For more information, please visit www.otometrics.com and www.natus.com.