Senior Regulatory Affairs Specialist

About Medline:

Medline India was setup in 2010 in Pune, primarily as an offshore Development center and to augment resources for Medline Industries LP headquartered in Chicago, USA. We are a 1300+ strong and growing team of technology, finance & and business support professionals who support our businesses worldwide towards a mission to make healthcare run better. Medline India is proud to be certified as a Great Place to Work by the Great Place to Work Institute (India) for the duration Jun 2025 Jun 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 in order to solve today's toughest healthcare challenges. These are testimonies to Medline been consistently ranked as Best Employers in multiple categories by Forbes for the last couple of years. We have also been listed at #16 place on Fortune 500 list with $20 Billion sales last year. At Medline India #PeopleMatter.

Medline Industries is a healthcare companya manufacturer, distributor and so much more, doing business in more than 125 countries and territories around the world. We provide the quality medical products and solutions our customers need to deliver their best care to every person in every care setting. Together, we free up the clinical and supply chain resources required to improve the overall operating performance of healthcare.

Job Description:

The Senior Regulatory Affairs Specialist is responsible for leading regulatory activities to ensure compliance with global regulatory requirements throughout the product lifecycle. This role provides strategic regulatory guidance, prepares and reviews regulatory submissions, and collaborates cross-functionally to support product development, approvals, renewals, and post-market compliance. This role will report to the QRA Manager in India & RA Director in Europe.

Primary job responsibilities:

• Development and maintenance of end-to-end Technical Files for the EU region as per EUMDR 2017/745 under little to no supervision.
• Ensure completeness and regulatory conformity of the Technical File, including GSPR checklist, risk management documentation, clinical evaluation, and PMS/PMCF etc.
• Support RA activities related to a Design change of the existing product portfolio or new product development.
• Supports the development of the regulatory plan, offering guidance on new product development and necessary actions to meet regulatory requirements such as CE Marking and other regional regulatory requirements.
• Reviews and validates labelling and marketing materials, providing support to projects and other key regulatory initiatives while ensuring compliance with regulatory guidelines and standards
• Work closely with cross-functional teams to gather required data, review technical inputs, provide regulatory guidance, and ensure that all product development and change management activities meet applicable regulatory requirements
• Support internal and external audits by providing accurate regulatory documentation, addressing queries, and ensuring audit readiness of Technical Files and associated records
• Implement basic knowledge and RA skills to develop different documentation/ reports of technical files periodically and make progress under moderate guidance.
• Manage individual projects by providing direction on diverse regulatory pathways, defining timelines for tasks and project teams, and recommending future actions and solutions.
• Develop and maintain regulatory strategies aligned with business priorities and evolving regulatory requirements
• In support of business priorities, determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in the assigned market(s). Identify factors that could impact the success or viability of new product launches in the assigned market(s). Monitor changes in regulations that impact current or future requirements and overall compliance for assigned divisional portfolios.
• Communicate the requirements of regulations to internal or external customers. Recommend regulatory pathways, strategies, and solutions for specific products and scenarios.
• Act as SME (Subject Matter Expert) in specific documents (e.g. Risk Analysis) by demonstrating sound functional / domain knowledge of the requirements, providing assistance, and resolving queries of team members. Also, perform peer review of team members technical documents.
• Help in developing and updating the TF /QMS SOP and template as per new requirements.
• Complete and maintain varied regulatory filings by leading internal groups, collaborating with external groups, evaluating and providing direction on supporting technical information, writing appropriate summary documentation, providing direction on product/project changes, and responding to non-conformances and questions from regulators.
  
  

Additional Responsibilities Include-

• Prepare and approve position papers with regulatory information as per request for tender or other support.
• Exhibits readiness to gather and understand the basic knowledge of Regulatory Affairs Processes in the EU & MEA regions.
• Express the willingness and ability to participate in team discussions for daily issues and try to question/challenge things as and when required.
• Extend help, support, and mentor team members, but also cross-regional teams (Including onboarding of new resources) to achieve results under little or no supervision.
• Should be contributing to the preparation of training/learning documents forthe RA European regions.
• Understands business requirements and problem statements and takes the lead to identify the required solutions under little or no supervision.
• Other than TF development, independently work on/execute breath of providing regulatory expertise in other RA teams of Medline Industries.
• Manage multiple priorities concurrently with accuracy and accountability.
  
  

Must Have:

• 7 to 10 years of core experience within the Medical Device industry with a strong Regulatory Affairs background.
• Experience in the development of CE technical files is a must.
• Expertise in the EU MDR 2017/745 regulation is a must.
• Knowledge and a good understanding of ISO 13485, ISO 14971, ISO 10993 & other relevant ISO standards.
• Excellent written and oral communication in English is mandatory to work in this international environment.
• Experience using time management skills such as prioritising/organising and tracking details and meeting deadlines of multiple projects with varying completion dates a plus.
• Must be a team player and able to work independently.
• Excellent Communication & collaboration skills, Open to new challenges.
• Excellent problem-solving and analytical skills
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook),
• Familiar with device design, manufacturing, and testing to understand technical reports.
  
  

Good to Have:

• Certification in EU MDR/ISO 13485/ ISO 14971 is an added advantage.
• Experience in the MEA, ANZ & Swiss region is an added advantage
• Experience using software like QAD, PIM, ETQ Reliance, Rimsys, Power BI, etc. is an added advantage.
  
  

Educational Qualification:

M. Pharmacy (Quality Assurance) /B. Tech (BioTech)/ .B.E. (Mech.)

Working Hours-

10.30 am to 7.30 pm