Sr. Manager Procurement -IPR & Regulatory

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Job Information

• Date Opened 12/31/2024
• Job Type Full time
• Work Experience 5+ years
• Industry Management
• City Pardi
• State/Province Gujarat
• Country India
• Zip/Postal Code 396191
  About Us
• MERIL
• DELIVERING WORLD-CLASS HEALTHCARE SOLUTIONS

Founded in 2006, Meril is an India-based, global medical device company that is dedicated to the innovation, design and development of novel, clinically relevant and state-of-the-art devices. Our fundamental aim is to champion the alleviation of human suffering and improve quality of life. To enable this, we are committed to R&D, innovation in manufacturing medical technology, scientific communication, and contemporary distribution avenues.

Meril was born with the aim of improving the quality of human life through innovative and advanced healthcare solutions. As a medical device manufacturer, we exist to improve the inventiveness in healthcare so that peoples lives are enriched. We continually seek excellence in providing answers to some of medicines toughest questions.

Meril manufactures medical solutions in the form of vascular intervention devices, orthopaedic supplements, in-vitro diagnostics, endo-surgery and ENT products. It is our core commitment to ensure the delivery of advance healthcare solutions. Our inclination towards research and development is reflected in our diverse offerings. We ensure that we adhere to the best quality of standards in manufacturing, scientific communication and distribution to deliver path-breaking healthcare products to the world.

We collaborate with physicians and global innovators to identify unmet clinical needs and develop revolutionary therapies. We encourage research and academic collaborations and remain available to interact on exciting opportunities.

Headquartered in India with a manpower of more than 4000, Meril currently conducts business in more than 100 countries. We have 100% subsidiaries in India, USA, Germany, Brazil, Russia, South Africa, Bangladesh and Turkey. We have set up operations in China and Japan too.

Job title : Procurement Specialist /Sr. Manager - Intellectual Property & Patent

The person procuring services related to Intellectual Property Rights (IPR) is typically responsible for acquiring external expertise to protect and manage an organizations intellectual property.

IPR Service Categories:

• Patent prosecution and maintenance
• Trademark registration and protection
• Copyright protection and licensing
• Intellectual property litigation
• IPR strategy and advisory services

• Knowledge of IPR laws and regulations
• Procurement expertise
• Contract negotiation and management
• Analytical and problem-solving skills
• Communication and project management skills
  Roles & Responsibilities:
• Sourcing and engaging IPR service providers (e.g., law firms, patent attorneys)
• Conducting Request for Proposal (RFP) processes for IPR services
• Evaluating and selecting IPR service providers
• Negotiating contracts and fees for IPR services
• Managing IPR budget and forecasting expenses
• Coordinating with external counsel on IPR matters
• Managing patent annuity and maintenance payments
• Ensuring timely delivery of IPR services
• Monitoring service provider performance and quality
• Resolving disputes or issues with service providers
• Collaborating with internal stakeholders (e.g., R&D, marketing) on IPR matters
• Ensuring organizational compliance with IPR laws and regulations & procurement policies
• Identifying and mitigating IPR risks
• Developing and implementing IPR policies and procedures
• Conducting IPR audits and due diligence
• Maintaining accurate records and documentation of IPR services
• Managing IPR-related contracts and agreements
• Processing invoices and payments for IPR services
• Reporting on IPR procurement performance and metrics
• Job title : Procurement Specialist/Sr. Manager - Regulatory- Medical Device

Regulatory Service Categories:

The person procuring regulatory services for the medical device industry is typically responsible for acquiring external expertise to ensure compliance with regulatory requirements. Key roles and responsibilities include:

• USFDA and international regulatory submissions (e.g., CE marking, Health Canada)
• Clinical trial management and monitoring
• Quality management system (QMS) implementation and auditing
• Regulatory strategy and compliance consulting
• Medical device classification and labeling

• Knowledge of medical device regulations (e.g., FDA, EU MDR, ISO 13485)
• Procurement expertise
• Contract negotiation and management
• Analytical and problem-solving skills
• Communication and project management skills

• Procurement
• Sourcing and engaging regulatory consultants or service providers
• Conducting Request for Proposal (RFP) processes for regulatory services
• Evaluating and selecting regulatory service providers
• Negotiating contracts and fees for regulatory services
• Managing regulatory budget and forecasting expenses
• Regulatory Compliance:
• Ensuring compliance with FDA, EU MDR, ISO 13485, and other relevant regulations
• Managing regulatory documentation and submissions
• Coordinating with regulatory authorities (e.g.,FDA,Notified Bodies)
• Conducting regulatory risk assessments and mitigation strategies
• Staying up-to-date with regulatory changes and updates
• Vendor Management:
• Coordinating with external regulatory consultants or service providers
• Managing vendor performance and quality
• Ensuring timely delivery of regulatory services
• Resolving disputes or issues with vendors
• Conducting vendor audits and due diligence
• Ensuring timely Payment to Regulatory bodies
• Project Management:
• Managing regulatory projects from concept to completion
• Coordinating with cross-functional teams (e.g., R&D,RA ,quality, manufacturing)
• Developing and implementing project plans and timelines
• Monitoring project progress and budgets
• Ensuring project deliverables meet regulatory requirements
• Communication and Collaboration:
• Collaborating with internal stakeholders (e.g.R&D, RA, quality, manufacturing)
• Communicating regulatory requirements and changes to stakeholders
• Providing regulatory guidance and support to project teams
• Participating in regulatory audits and inspections
• Ensuring regulatory compliance across the organization

Education and Certifications IPR:

• Bachelors degree in law, business, or related field
• Certified Procurement Professional (CPP) or Certified Professional in Supply Management (CPSM)
• Certified Intellectual Property Manager (CIPM) or Certified Patent Professional (CPP)

• Bachelors degree in life sciences, engineering, or related field
• Certified Regulatory Compliance Manager (CRCM)
• Certified Quality Engineer (CQE)
• Certified Medical Device Auditor (CMDA)
• RAC (Regulatory Affairs Certification) - US, EU, or Canada

Enhancing and decentralization of Service procurement in terms of quality, TAT & Cost.

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