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Danaher Corporation Senior RA/QA Specialist in Kurla, India

Position Summary

The Senior RA/QA specialist is responsible for regulatory compliance of IVD products imported by Leica Biosystems according to India CDSCO regulation and other relevant local regulations. In addition, this position is responsible for establishing and managing the quality system of the company to ensure medical devices sold by Leica Biosystems are handled in compliance with a local regulation and the quality is managed throughout product importing and distribution process.

This position will report to RA manager APAC.

Key Responsibilities

Regulatory affairs

  • Follow Medical Device Act by CDSCO and other relevant regulations related to products of Leica Biosystems and provide directions for compliance to the organization.

  • Perform IVD Product registration (Class I/II/III) with CDSCO in time and in accordance with global product launch schedule and local launch plan.

  • Prepares dossiers and device master files for regulatory submissions

  • Ensures maintenance of licenses and completes license renewals as required

  • Effective operate regulatory pathway for Life Science (Chemical products, Broadcasting & Communication equipment) products in India

  • Plan a registration timeline with commercial team strategically

  • Communicate and align with global regulatory team to get support for local product registration and manage local regulatory system and processes.

  • Provide regulatory support to marketing, sales and FSE.

Quality assurance

  • Establish and manage quality policies and standards for Leica Biosystems India.

  • Lead quality board.

  • Define process for product import, warehousing, labeling and delivery to ensure sustained quality of products sold.

  • Manage product return process and CAPA process to correct quality issues.

  • Develops and ensures post market surveillance for IVD products.

  • Lead a quality audits conducted by global and local authorities.

Required Education, Experience, Skills

  • Bachelor’s degree or higher (Bio, Chemical)

  • Minimum 7 years of experience in medical device regulatory affair and/or quality assurance field

  • Deep knowledge and experience for IVD product registration and evaluation act

  • Comprehensive knowledge and experience for broadcasting and communication equipment act

  • University graduate with major in Science (Pharmacist is preferred but not necessary)

  • Working experience at CDSCO and/or equivalent agency

  • Proficient and well-versed in Medical device act and ISO 13485

  • Pathology background with biologics and chemical

  • Good command of written and spoken English

  • Business travel: 10% of total working time

Personal Trait Profile

  • Highly Organized, process orientated and adherence to standard process.

  • Exhibit good leadership across departments and teams.

  • Good time management and project management.

  • Collaborative and a team player

  • Good interpersonal, listening and communication skill.

  • High degree of integrity, discrete and honest

Key Relationships

Internal

  • APAC RA/QA manager and India general manager

  • Quality board consisting of logistics, service and marketing managers

  • RA/QA managers in manufacturing sites

External

CDSCO, Notified body and other associations for medical device regulation

Scope of the Role

Supervisory Responsibility: NA

Approximate Direct Reports:

Nil

Approximate Indirect Reports:

Nil

Financial Responsibility

Nil

Domestic/International/Global:

Physical Demands & Working Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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