Regulatory Affairs Specialist Jobs in Pune - Medline India

About Medline

Description du poste

Medline is America's largest privately held national manufacturer and distributor of health care supplies and services. Today, Medline manufactures and distributes more than 550,000 medical products, encompassing medical-surgical items and one of the largest textile lines in the industry. With 17 manufacturing facilities worldwide and over 25 joint venture manufacturing plants worldwide, along with 45 distribution centers in North America and 50 throughout the world, Medline posted $ 13.9 billion revenue last year. Medline is ranked #27 in Forbes 2019 list of America’s private companies.

Medline Industries India Pvt. Ltd. is engaged in providing offshore business support services to Medline Industries Inc. & its global associate companies in the area of Information Services, Finance & Business processes Management. Medline Industries India Private Limited was setup in 2010 in Pune, India and today we are proud team of 700 plus associates supporting Medline’s healthcare vision across USA, Europe & other International regions.

Why Join Medline

• A direct, full-time employment in a large, stable, rapidly growing and yet profitable company.
• Privately owned company with no public debts.
• No ill effects of recent downturn/recession.
• First-rate compensation and benefits package.
• Genuine individual growth potential in this new establishment.
• Open door and highly ethical work culture, with due accountability.
  

Job Description

This position is responsible to assists the Regulatory Affairs Dept. for ensuring regulatory compliance set by the EU Medical Device Regulation (MDR 2017/745) and other regulatory bodies in Europe. Including supports the development of internal RA systems and procedures. Reporting to the senior manager in India & Europe.

Required Skills

• Experience in development of CE technical file is must.
• Expertise in EU MDR 2017/745 regulation is must.
• Good understanding of ISO 13485:2016 & QMS documentation is must.
• Certification in EU MDR or ISO 13485 is added advantage.
• Experience in DHF development is added advantage.
• Familiar with device design, manufacturing, testing in order to understand the technical reports.
• Very good written and oral communication in English.
• Strong technical writing skills.
• Able to work with minimal supervision.
  

Responsibilities

• Maintains existing and develop new technical files / design dossiers by reviewing and updating the related documentation, to support CE mark of EU products.
• Ensures that EU regulatory requirements are fulfilled, this includes the Essential Requirement/ GSPR checklist, list of applicable International Standards or guidance documents, risk analysis, communication with the suppliers, test report, and Clinical Evaluation Report development.
• Archives the approved documents on the server.
• Review labelling (Labels & IFU) and marketing materials for compliance with EU regulations; recommends appropriate changes.
• Prepares position papers/statements requested by customers/sales.
• Performs a Regulatory watch to identify and respond to new or revised regulatory requirements including regulatory gap analysis.
• Maintains SOPs related to Medline India RA activity and suggests updates in the QMS.
• Monitors the local RA activity and provide periodical feedback to his/her manager.
• Maintains regulatory knowledge of European regulations within Medline India in Pune.
• Assist in other Quality and Regulatory areas as necessary to support goals and objectives (Validation, Supplier Change Control, Quality Systems, Quality Audits, etc.).
  

Work Experience

5 to 7 years

Educational Qualification

M. Pharmacy/ B.E. Biomedical / B.E. Mech.