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Job details
Job type full-time
Full job description
Summary of the job:
Execute quality and regulatory processes in india and emerging asia (singapore, thailand, malaysia, indonesia, and philippines)
Support acquisition and integration activities of the company
Act as cordis’ qa & ra representative for local authorities under area of responsibility
Oversee and ensure compliance of the quality activities of 3pl, lsp and distributors in india and emerging asia
Develop and implement regulatory strategies and processes to assure timely commercialization of products in compliance with applicable regulations and standards in responsible countries
Ensure that regulatory requirements are met in regard to local and national laws and company standards in order to place and/or maintain products on the markets
Responsible for communicating business related issues or opportunities to next management level
For employees with supervisory responsibilities, ensure that subordinates follow all company guidelines related to health, safety and environmental practices and that all resources needed to do so are available and in good condition
Responsible for ensuring compliance with quality procedures, laws and regulations of the applicable
Essential duties and responsibilities:
Act as management representative at the country and regional level
Execute quality processes:
Ensure compliance to cordis quality management system, iso certification and local country regulations as applicable
Ensure all complaints related to products are reported according to policies and procedures, and support communication to authorities as necessary
Manage internal and external audits, inspection readiness and regulatory authority inspections
Coordinate nonconformance, corrections and corrective and preventive actions
Manage the local qms, escalation of quality and regulatory issues, and local field action activities as required
Review and approve translations of product labeling (e.g., labels, ifu, user manual…) and promotional material (external and internal communication)
Understand local labeling requirement and ensure all activities related to product labeling are performed correctly
Act on field remedial actions and fsca communicated by cordis corporation according the cordis corporation procedures
Execute stop-shipments/ field actions initiated by cordis corporation and ensure compliance with cordis procedures
Manage documentation of the quality management system according the cordis corporation procedures
Coordinate corrective and preventive actions
Responsible for ensuring subordinates follow all company guidelines related to health, safety and environmental practices and that all resources needed to do so are available and in good condition
Execute regulatory processes:
Ensure regulatory compliance of medical products to international, regional and national laws and company standards in order to place and/or maintain products on the markets: life cycle management, notification and communication to national competent authorities, etc…
Support registration, notification of cordis products in accordance with national regulations in a timely manner
Provide, in coordination with cordis, authorized representatives and manufacturers, regulatory support (communication of regulatory documents or information, answer to regulatory and technical questions on products, agreements…) for marketing department, medical devices representatives, he&r department, customers
Maintain product, distribution and reimbursement licenses per country requirements
Ensure access to the market, distribution of the products, life cycle management, declaration to government regulatory authority
Contribute to regulatory intelligence (involvement on internal and external working group, participation to meetings and congresses)
Fully responsible for implementing pra for the countries under scope
Copy clearance: review and approve translations and content of advertising material as per an established process
Ensure compliance with environmental regulations
Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups globally to support education of local regulations
Instill and drive a regulatory cultureEstablish and support policies and standards for the measurement of new products
Contribute to regulatory intelligence (involvement on internal and external working group, participation to meetings and congresses)
Responsible to assess impact of regulation changes for countries under area of responsibilities
Ensure regulatory and quality training and assessments for sales & marketing department and for any other concerned employees
Support record retention appropriately
Responsible for communicating business related issues or opportunities to next management level
Responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies, and procedures
Responsible for ensuring compliance with quality procedures, laws and regulations of the applicable markets
For employees with supervisory responsibilities, ensure that subordinates follow all company guidelines related to health, safety and environmental practices and that all resources needed to do so are available and in good condition
Clinical studies application as necessary
Manage subordinate staff
Performs other duties as needed and assigned
Education/training and/or experience:
A minimum of a bs degree, or equivalent, in relevant discipline
7+ years of related quality engineering, quality compliance, quality systems or regulatory affairs experience within the medical product industry, preferably medical or combination devices
Company acquisition & integration experience preferred
Overseeing quality activities of 3pl preferred
Preferred to have experiences in singapore, thailand, malaysia, indonesia, and philippines
Required knowledge, skills, abilities and certifications/licenses:
Consistent background and knowledge of medical device regulations and quality requirements
Proven expertise in all aspects of regulatory affairs, submission preparation, local regulatory body device law/regulations, world wide regulatory requirements/procedures, project management, and negotiations
Ability to identify early the risks incurred by the company, to make the necessary warnings and propose appropriate action plans, in agreement with the quality assurance and regulatory affairs director
Experience in working with virtual teams in a global environment is highly desired
Experience with sop development and working knowledge of qsr (iso 13485, 21cfr820) is required
Must possess knowledge regarding local cdsco and global medical device regulations (21cfr 803, 806, 820; mdd, meddev 2.12-1, iso 13485, iso 14971,
Must be highly effective in communication skills, both written and oral, for both english
Consistent background and knowledge of cdsco medical device regulations and other local country regulations
Relations established with the key interlocutors in the network of the mds (e.g., regulatory agencies such as cdsco, professional organizations, )
Ability to identify early the risks incurred by the company, to make the necessary warnings and propose appropriate action plans, in agreement with cordis quality compliance management
Lead auditor certification or training is highly desired
Industry relevant certifications in auditing and/or quality engineering are highly desired
Ability to work in team and to share experiences
Additional position requirements include whether or not position will be required to work in clean room, near or with heavy machinery, ability to lift heavy objects, ability to wear protective gear in lab, etc
Travel: 10% to 20% (international and domestic)
Occasional weekend/travel work may be required as necessary
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General provisions:
Company management reserves the right to add, delete or otherwise alter assigned duties at any timeTo perform this job suc cessfully, an individual must be able to perform each essential duty satisfactorilyThe minimum qualifications listed are representative of the knowledge, skill, and/or ability requiredReasonable accommodations may be made to enable individuals with disabilities to perform the essential functionsThe above statements are intended to describe the general nature and level of the work being performed by people assigned to this classificationThey are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
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Posted 4 days ago
