Senior Regulatory Affairs and Quality Specialist

Cochlear is the global market leader in implant hearing solutions. Cochlears mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer from severe hearing loss. It s an incredible piece of engineering and the only product in the world that restores a sense through technology. Imagine using your experience to help people around the world to hear again. Our mission is to help more people to hear.

Position Overview / Purpose: Accountabilities: Accountability 1: Regulatory Champion/Representative

• Provide critical regulatory timelines to support accurate planning, forecasting and budgeting for the SA Markets
• Champion and represent SA when liaising and collaborating with Global and Asia Pacific (APAC) counterparts for Regulatory Affairs requirements as part of the Cochlear Product Innovation Process.
• Lead a culture of business (code of conduct)/regulatory (local legislation) compliance in SA and provide guidance and support to the Cochlear team and distributor team members to ensure compliance
• Drive compliance to all applicable regulations to Cochlear products, including BIS, EWaste, Plastic Waste, Telecommunications and CDSCO regulations

Accountability 2: Regulatory Product Registrations

• Implement product registration plans and communicate status to relevant stakeholders to deliver timely product submissions and approvals
• Participate in the APAC New Product Introduction (NPI) process to ensure that all regulatory requirements are communicated between SA and APAC and satisfied for timely product launch
• Establish and maintain regulatory files and licenses in a format consistent with legislative requirements and business requirements
• Build and maintain relationships with relevant industry associates, regional regulatory authorities across the SA region and Cochlear global teams

• Facilitate communication with applicable regulatory agencies and authorities during ongoing review of submissions.
• Follow up all submissions and post-approval commitments and renewal activities in a timely manner

Accountability 3 : Quality Management System

• As the Quality representative for SA, fulfil all requirements related to the quality function in partnership with the Global and APAC Regional teams
• Establish and maintain a Quality Management System that supports operational excellence and achieves Good Importation Practice (GIP) and Good Distribution Practice (GDP) certification across SA markets, as required
• Manage quality related issues and mandatory reporting to auditors
• Oversee local inspection activities for products and the inventory database for quality requirements

Accountability 4 : Surveillance and Compliance

• Review sales and marketing literature and product labelling for approved product claims and regulatory compliance
• Partner with the SA Marketing team to develop marketing collateral and procedures that are complaint with regulatory standards
• Participate in Cochlear s post market surveillance system and ensure that it is compliant with SA s regulatory requirements

Team Role (Individual contributor):

• Follow relevant quality procedures in order to deliver quality products and services and identify and support the implementation of continuous improvement. Undertake additional quality responsibilities (e.g. audit) when appropriately trained to undertake these responsibilities.
• Contribute ideas on systems and process methods to improve deliverables.
• Work safely, complying with all safety procedures, rules and instructions; and reporting workplace hazards, incidents or injuries to manager.

Minimum:

• Bachelor s degree in engineering, pharmaceutical, medical, legal, science or relevant field
• 8+ years of professional experience in regulatory affairs with demonstrated knowledge/experience in:
  • Broad knowledge of medical device regulations associated with the product development and approval process in India
  • Proven track record of management, compilation, submission, approval and maintenance of regulatory filings
  • Interacting directly with government agencies, industry bodies and health care professionals in order to meet designated timeframes and maintain compliance
  • Creativity, foresight and ability to provide input into activities of importance
• Strong written and verbal English language skills
• Written and verbal English language competency
• Demonstrated leadership qualities; sound judgment, engaging interpersonal skills, effective communication, ability to negotiate and influence, initiate collaboration and project manage
• Collaborative mindset and team player across culturally diverse stakeholders
• Ability to work under pressure and to tight deadlines
• Ability to work autonomously in performing tasks according to an agreed plan

Cochlear s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry s best clinical, research and support networks. That s why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life s opportunities.

If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.

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How we recognise your contribution

We want Cochlear to be a place where our people truly enjoy coming to work. Through our internal programs and employee benefits, we aim to create an environment where our people will feel value and supported. Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs in place to support you.

At Cochlear we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential.