Premarket Quality Assurance and Regulatory Affairs Expert

Premarket Quality Assurance and Regulatory Affairs Expert

Join us as a Premarket Quality Assurance and Regulatory Affairs Expert at Dedalus, one of the Worlds leading healthcare technology companies, on our Team at Chennai, India to do the best work of your career and make a profound impact in providing better care for a healthier planet.

What youll achieve

As a Premarket Quality Assurance and Regulatory Affairs Expert you will provide guidance and define regulatory plans and strategies, working with the project core team. You will also be accountable for the implementation of the pre-market regulatory procedures and the compilation of regulatory clearance documentation to achieve timely regulatory clearances

You will:

• Ensure the ongoing Quality and Regulatory compliance of products and services.
• Will drive and manage the implementation of the DH Healthcare GmbH Quality Management System to the Site in India.
• Ensure the effectiveness of Quality Management System in the Indian Organization.

Take the next step towards your dream career

Dedalus is committed to providing an engaging, rewarding work experience that reflects the passion our employees bring to our mission of helping organizations deliver better care to their communities. Heres what youll need to succeed:

Essential Requirements

• Good experience in a regulated industry preferably medical device, pharmaceutical or related holding a position in project management, quality management, or quality assurance and regulatory affairs position.
• Subject matter expert in regulatory affairs with in-depth knowledge of relevant health care quality standards and requirements including ISO 13485, ISO 14971, IEC 62304, IEC 62366, EU Medical Device Directive, EU Medical Device Regulation (MDR and IVDR) and regulatory requirements in other territories.
• Knowledge of and experience in: Quality Management Systems, Internal and External Audits.
• Medical device regulatory submission regulations and requirements. CAPA/NCR regulations and requirements

Desirable Requirements

• Awareness of Medical Device product safety and Security Standards including ISO 27001 GDPR (Preferable)
• Awareness of other international system and product regulation in Medical Device Industry
• Expert PC operation skills, including knowledge of enterprise-wide software applications
• QMS tools (CAPA, regulatory clearances, KPIs) (Preferable)

We are Dedalus, come join us

Dedalus is committed to providing an engaging, rewarding work experience that reflects the passion our employees bring to our mission of helping clinicians and nurses deliver better care to their served communities.

Our company fosters a culture where employees are encouraged to learn and innovate, and to enable and enhance clinical co-operation and processes while making a meaningful difference for millions of people around the world. Each person is the end point and the starting point of the Groups activities and the ultimate beneficiary. For this reason, we are so proud of doing our very special jobs each day.

Our company is enriched by a diverse population of 7,600 people in more than 40 countries that work together to innovate and drive better healthcare options for millions of patients around the world. We are the people of Dedalus.

Application closing date: 1st February 2025

Our Diversity & Inclusion Commitment sets out Dedalus approach to ensuring respect, inclusion and success for all our colleagues and the wider communities we operate in. It is imperative for us to share our commitment and dedication to ensure an inclusive and diverse workplace. We recognise that we have improvements to make and, on this journey, we must remain authentic and realistic but also ambitious.

Our diversity & inclusion commitment Dedalus Global

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