Senior RAQA Associate - ANZ
About Medline:
About Medline India:
Medline India was setup in 2010 in Pune, primarily as an offshore Development centre and to augment resources for Medline Industries LP headquartered in Chicago, USA. We are a 1500+ strong and growing team of technology, finance & and business support professionals who support our businesses worldwide towards a mission to make healthcare run better. We are proud to be certified as a ‘Great Place to Work’ by the Great Place to Work Institute® (India) for the duration June 2025 – June 2026.We are an organization with a conducive work environment, ample opportunities to learn, contribute and grow with a highly empowered & engaged team. We encourage our people to share their best ideas and create new opportunities for our customers and ourselves to work together to solve today’s toughest healthcare challenges.
About Medline Industries, LP:
Established in 1966, Medline Industries LP is a renowned global healthcare organisation boasting 56 years of consecutive sales growth, exceeding $21 billion in annual sales. With a workforce of over 36,000 professionals spread across the globe, we operate in more than 125 countries and territories. As the largest privately held manufacturer and distributor of medical supplies in the United States, Medline is uniquely positioned to offer comprehensive products, education, and support across the continuum of care.At present, Medline Industries, LP holds the esteemed position as the #1 market leader, delivering an extensive portfolio of over 550,000 medical products and clinical solutions. Our clientele includes hospitals, extended care facilities, surgery centres, physician offices, home care agencies, providers, and retailers.We're proud to be recognised by Forbes as one of America’s Best Large Employers and Best Employers for Women. Additionally, the Chicago Tribune has consistently named us a Top Workplace for the past 12 years.
- Our Pune, India location currently has an exciting opportunity for a Senior Regulatory Affairs Associate within the Regulatory Affairs team for the ANZ market. This role plays a key part in upholding quality standards aligned with our strategic engineering objectives.
- This role will ensure regional-specific RAQA requirements for ANZ are identified, represented, and included in the manufacturer’s technical documentation supporting local registrations.
- In addition to supporting ongoing QA & RA functions, this position contributes to both new product development and legacy engineering projects related to the ANZ market.
- We are looking for someone who thrives in a team environment, demonstrates a strong sense of urgency, and can build and maintain effective working relationships with peers, customers, and suppliers.
- The role reports to the QRA Manager in India and the Senior Manager RAQA Australia.
Key Responsibilities
RA Activities:
- Create and maintain documentation to meet regional-specific requirements (e.g., EPC, Australian DoC).
- Ensure regional-specific requirements are documented within the LM technical file (e.g., technical file addendum covering regional testing arrangements).
- Ensure labels meet regional-specific requirements and Review and update label changes as needed.
- Identify regional-specific requirements impacted by changes.
- Facilitate coordination with relevant stakeholders and update technical file documentation to enable changes with minimal disruption (e.g., testing from new vendors, material validations).
- Assess, facilitate, and complete technical file documentation for new products.
- Build new technical files or expand the scope of existing technical files within the legal manufacturer’s certification framework to support New Product Introductions (NPI/NPL).
- Provide visibility and access to the local RA team to technical documentation for the provision of information in response to customer queries and tenders.
- Create and provide documentation for local registration submissions.
- Assist with application audits and respond to queries or investigations from local regulators.
QA Activities:
- Work with relevant stakeholders to identify applicable standards and requirements to meet the “state-of-the-art” (SOTA) upon commercial expectations set for ANZ’s product range.
- Identify discrepancies in the technical file SOTA standards compared to regional-specific requirements.
- Coordinate with contract manufacturers and external laboratories to obtain test reports, perform testing and implement ongoing testing processes demonstrating compliance requirements for ANZ’s product range and maintain accreditations as appropriate.
- Complete assessments and validations/testing to expedite change processing (e.g., material validations, vendor assessments, performance testing/equivalencies).
- Conduct document reviews to validate claims in marketing collateral and labels.
- Develop equivalency and justification statements, perform risk assessments to support these, and create customer letters for performance test claims.
- Prepare Certificates of Analysis (CoA) or Certificates of Conformance (CoC) for customers.
- Draft statements to substantiate claims and ensure adherence to SOTA standards in response to customer queries and tender submissions (e.g., explaining differences in technical file standards like US/FDA and ISO vs. EU/EN).
Must Have
- Degree or higher in B. Tech (Biomedical)/ B.E. (Mech)/ M. Pharm. (Quality Assurance).
- 3-to-5-years work experience within the Medical Device industry with a strong Regulatory or Quality background.
- Familiarity with 21 CFR Part 820, EU MDR 2017/745, MDSAP, ISO 13485, ANZ MD regulation, and requirements.
- Proficiency in ISO 14971, ISO 10993 & other relevant ISO standards.
- Demonstrates excellent communication skills to convey clear, concise messages and instructions to internal and external stakeholders, ensuring alignment and understanding.
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook): Able to create and format professional documents, analyse and organise data, prepare clear presentations, and manage communication and scheduling effectively.
- Strong attention to detail and organisational skills: Ensures accuracy and compliance in data entry and documentation, maintains structured records, and manages multiple tasks efficiently.
- Demonstrates a strong focus on outcomes by setting clear goals, taking ownership, and consistently delivering high-quality results that align with business objectives.
Good to Have
- Experience in working with the TGA/ANZ regulatory environment.
- Experience with ETQ Reliance, SAP, and QAD platforms.
- Experience with QMS and technical documentation (e.g., interpreting standards, conducting gap analyses, producing reports, developing documentation, performing risk assessments).
- Exposure to global quality systems and multi-country document management.
- Ability to work independently and in a global team environment.
- Proficiency in ISO 14971, ISO 10993 & other relevant ISO standards.
- Exposure with continuous improvement and a creative environment adds value.
Working Hours:
10.30 am to 7.30 pm IST
