We protect lives worldwideWith over 135 years’ experience, schulke is one of the world’s market leading names in infection prevention, currently selling over 300 products in over 100 countries and employing over 1300 people worldwide. Our products are market leaders in the areas of disinfectants, antiseptics and medical skin care products. Incorporated in 2015, schulke Australia Pty Ltd operates as part of the APAC region, supporting consumer health and having the privilege to support healthcare providers in their quest to deliver safe and quality healthcare. As a team, we value Trust, Passion, Quality and Innovation. The RoleAs a growing business, schulke Australia Pty Ltd is welcoming applications for a Regulatory Affairs and Quality Manager to join the team, working for three days per week. A pivotal role contributing to ongoing success of our infection prevention and control business across both Australia and New Zealand. Based in Sydney or Brisbane and reporting to the Managing Director and APAC functional teams, this newly created role is of crucial importance in contributing to the supply of high-quality product to market.
Key responsibilities and activities:· Learn and develop expertise in schulke products and associated technical and market areas that supports value creation to the commercial team· Formulation and submission of product technical files and dossiers for new and existing product registrations with local authorities, across various product types (registered medicines, medical devices and cosmetics)· Manage projects and collaborate with local, regional and global product management, quality and sourcing teams for product development, improvements, changes or recalls · Collect, share and consolidate market and competitor regulatory affairs intelligence, contributing to company strategy and collaborating with the commercial team to support short- and long-term planning of activity and product lifecycle management· Maintain company ISO certifications and effectively manage the Quality Management System· Lend expertise in Quality and GMP principles to support manufacturing partners · Lead and manage the product quality and pharmacovigilance programs · Implement and maintain functional area policy, process, internal controls and reporting · Maintain external networks and current expertise in Regulatory Affairs, Quality and Pharmacovigilance· Maintain documents and records according to authority requirements and best practice retention principles· Demonstration of schulke company values, contributing to a high performing collaborative culture · Compliance to safe work practices and adherence to company policy Who you are You are able to work autonomously and alongside a close-knit team, demonstrating high energy, self-motivation and a determination to succeed and deliver on outcomes required. With a proven track record in Regulatory Affairs and Quality, you will have the ability to work across the different but related functional areas of this role. Previous experience in the Infection Prevention and / or Retail Pharmacy area is highly regarded. You will be an excellent communicator with an engaging and influential style, be articulate with high attention to detail, demonstrate willingness to adapt to change, be highly organised and manage time well. Further you must be:· Degree qualified in an appropriate scientific or health field · Mobile and prepared to travel across Australia and New Zealand for business commitments, including occasional international travel· Proficient in Microsoft Office applications, regulatory authority platforms and document sharing software · Able to comply with company policies· Able to provide proof of your ability to work in Australia and hold a current and valid driver's licence· Willing to undertake and provide evidence of an Australian Federal Police Check What we can offer you The successful applicant will have the opportunity to experience a role with great purpose and visibility that will contribute and shape a growing business for a successful, market leading future. Working with schulke is an opportunity to work for a professional, yet fun business with strong values and culture, that rewards for high performance with a competitive salary, superannuation and generous bonus scheme.So, if this sounds like you and if working to foster safe and quality healthcare is your passion, schulke welcomes your application, join us and apply now.