Head - QRA/IVD & Medical Devices - Global Diagnostics Firm

Head QRA_IVD & Medical devices_Global Diagnostics Firm_Mumbai

Job Description:

Head of QRA will be responsible for overall quality and regulatory assurance in India, ASEAN region, Korea and ANZ. The position will lead the regional/ country QRA leads and partner with the Director of Compliance and Country Managers to ensure alignment and compliance of Quality systems and regulatory needs in the regions/ country as per local country guidelines and regulation. He/She will also be part of the ASPAC Leadership Team.

Client Details :

The company is leader in developing and manufacturing innovative technologies that raise the performance of diagnostic testing and create better patient outcomes across the entire healthcare continuum. It is an in-vitro diagnostics company that makes products and diagnostic equipment for blood testing majorly, among other medical equipment.

Description :

Major Duties & Responsibilities :

- Leading the India QRC organization

- Leads or manages others responsible for audits, registrations, corrective actions and ensures compliance with local regulators and Health Authorities

- Proactively monitors, analyzes and improves all aspects of quality compliance, quality control and customer complaint process in order to drive the Total Customer Experience.

- Represent company interests with national government agencies, industry or standards associations and/or other organizations in India, ASEAN region, ANZ and Korea for the purpose of ensuring compliance with legislation, regulations and/or guidelines that impact the business in the clinical diagnostic market.

- Responsible for escalation of relevant issues within the company, facilitating the non-conformance and CAPA processes, ensuring compliance with customer complaint, adverse event, and FSCA processes, and all quality assurance components of the company

- Provides region-wide leadership for implementing and continuously improving quality, Quality Management Systems and compliance to ISO standards including ISO 13485 and country regulations

- Develop regulatory strategies, policies, guidelines, programs, procedures and investigative approaches and metrics to track compliance.

- Act as the primary authority for internal quality compliance matters

- Lead and manage a team of regional QARA leads in the region

Other Duties:

- Participate in global initiatives as needed.

Profile :

Qualifications:

Minimum Education or Equivalent Experience Required / Preferred:

- Bachelor's Degree -Technical / Post Graduate preferred

- Advanced certification and knowledge on quality and regulatory processes in ASPAC

Minimum Years of Related Knowledge, Skills and Abilities Required/Preferred :

- 10+ years of Quality and Regulatory Affairs experience

- 5+ years in regional roles in ASPAC regions or India based roles

- Diagnostic/Medical Devices industry experience is preferred

- Very good communication, presentation and platform skills, financial/business acumen, organizational and people management skills

- See citical competencies (Leadership Attributes) below

Job Offer :

- Opportunity to work with the fastest growing company in the industry.

- Be part of their expansion journey & be part of the leadership team.

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Ananya Saxena on +91 (0) 22 4236 3217.

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