Sr Manager Procurement -IPR Regulatory

Meril

Posted on : 05-04-2025

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1 Vacancy

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Job Location

Pardi - India

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 05-04-2025

Job Description

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:
1. Patent prosecution and maintenance
2. Trademark registration and protection
3. Copyright protection and licensing
4. Intellectual property litigation
5. IPR strategy and advisory services

Desirable Skills:
1. Knowledge of IPR laws and regulations
2. Procurement expertise
3. Contract negotiation and management
4. Analytical and problemsolving skills
5. 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 IPRrelated 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
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:
Regulatory Service Categories:
1. USFDA and international regulatory submissions (e.g. CE marking Health Canada)
2. Clinical trial management and monitoring
3. Quality management system (QMS) implementation and auditing
4. Regulatory strategy and compliance consulting
5. Medical device classification and labeling

Desirable Skills:
1. Knowledge of medical device regulations (e.g. FDA EU MDR ISO 13485
2. Procurement expertise
3. Contract negotiation and management
4. Analytical and problemsolving skills
5. Communication and project management skills

Roles & Responsibilities:
a) Procurement
1. Sourcing and engaging regulatory consultants or service providers
2. Conducting Request for Proposal (RFP) processes for regulatory services
3. Evaluating and selecting regulatory service providers
4. Negotiating contracts and fees for regulatory services
5. Managing regulatory budget and forecasting expenses

b)Regulatory Compliance:
1. Ensuring compliance with FDA EU MDR ISO 13485 and other relevant regulations
2. Managing regulatory documentation and submissions
3. Coordinating with regulatory authorities (e.g.FDANotified Bodies)
4. Conducting regulatory risk assessments and mitigation strategies
5. Staying uptodate with regulatory changes and updates

c) Vendor Management:
1. Coordinating with external regulatory consultants or service providers
2. Managing vendor performance and quality
3. Ensuring timely delivery of regulatory services
4. Resolving disputes or issues with vendors
5. Conducting vendor audits and due diligence
6. Ensuring timely Payment to Regulatory bodies

d)Project Management:
1. Managing regulatory projects from concept to completion
2. Coordinating with crossfunctional teams (e.g. R&DRA quality manufacturing)
3. Developing and implementing project plans and timelines
4. Monitoring project progress and budgets
5. Ensuring project deliverables meet regulatory requirements

e)Communication and Collaboration:
1. Collaborating with internal stakeholders (e.g.R&D RA quality manufacturing)
2. Communicating regulatory requirements and changes to stakeholders
3. Providing regulatory guidance and support to project teams
4. Participating in regulatory audits and inspections
5. Ensuring regulatory compliance across the organization

Requirements

Education and Certifications IPR:

1. Bachelors degree in law business or related field

2. Certified Procurement Professional (CPP) or Certified Professional in Supply Management (CPSM)

3. Certified Intellectual Property Manager (CIPM) or Certified Patent Professional (CPP)

Education and Certifications Regulatory:

1. Bachelors degree in life sciences engineering or related field

2. Certified Regulatory Compliance Manager (CRCM)

3. Certified Quality Engineer (CQE)

4. Certified Medical Device Auditor (CMDA)

5. RAC (Regulatory Affairs Certification) US EU or Canada

Benefits

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

Required Experience:

Manager

Employment Type

Full-Time

Company Industry

Key Skills

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About Company

Meril

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Sr Manager Procurement -IPR Regulatory

Meril

Job Description

Requirements

Benefits

Employment Type

Company Industry

Key Skills

About Company

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