Regulatory Affairs Executive

2+ years

Not Disclosed

Ahmedabad

15 June 19, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About the job

Title/Designation: Regulatory Executive

Based at: Ahmedabad

Industry: Medical Devices manufacturing (Class III)

Qualification: Postgraduate or equivalent in Pharma/Medical Devices domain

Experience: more than 2 years will be preferred

Reports to: Head of RA / RA Manager

About us:

Aegis Lifesciences, established in 2008, is a distinguished manufacturer and exporter of medical devices, headquartered in India. Renowned for its state-of-the-art facilities, Aegis specializes in the production of high-quality absorbable and non-absorbable haemostats, serving a diverse clientele across the globe.

· Global Reach: Aegis caters to quality-conscious markets worldwide, including the EU, NHS-UK, CIS, Central America, Russia, LATAM, MENA, SA, and SEA

· Remarkable Growth: With an impressive yearly growth rate exceeding 30%, Aegis has demonstrated substantial success in expanding its product portfolio and market presence

· Quality Standards: Aegis upholds the highest quality standards, holding certifications such as ISO:13485, MDSAP, and CE (Class III medical devices). The company's facilities are registered with the United States Food and Drug Administration (FDA), reinforcing its commitment to quality and compliance

Aegis Lifesciences continues to drive innovation and excellence in the medical device industry, making significant contributions to global healthcare.

About the role:

We are seeking experienced candidates to join our dynamic team in the Quality Assurance / Regulatory affairs, in the field of class III / class D Medical devices Certification, QMS & Quality Assurance, Regulatory Compliances

As part of this role, you will be responsible for taking a leading role in the RA team and handle products registration and license renewal in various countries, compliance for international as well as local regulations for various class of medical devices. If you have proven expertise in this domain and like to take a leadership role in the QA/RA domain in the healthcare industry, we encourage you to apply and embark on a rewarding career journey with us.

Responsibilities

The Senior RA Executive shall report to the Head of QA/RA, and is responsible to assist him in the following areas:

· Leading new product registrations and license renewals in various regulated/semi regulated countries

· Compliance for international as well as local regulations for various class of medical devices in the regions where they are distributed.

· Preparing the responses against the queries raised during the registration of medical device products.

· To Lead QA/RA team and ensure the preparation and maintenance of regulatory/quality SOPs within the company

· Have the joint responsibility to develop, facilitate and execute comprehensive regulatory strategies through all phases of development and product life cycle, to accelerate and ensure successful product registrations and provides regulatory assessment and supports Change Control Assessment

· Oversee maintenance of product quality and compliance through the Quality Assurance functions as well as management of the Quality Management System and compliance processes

· Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects

· Keep abreast of International legislation and guidelines of current product line in India

· Compliance with respect to internal/external audits meeting regulatory/ accreditation requirements

· Reviewing current accreditation/regulatory requirement, performing gap analysis and ensuring compliance to current requirements

· Provide product specific Regulatory strategies to mitigate risk; works in conjunction with production, RA & QA team to provide advice on process and labelling changes

· Review of SOPs, BPRs, specifications and change control to ensure compliance

· Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks

· Drives resolution of issues, communicates issues, impact and outcomes to the management team

· Responsible for ensuring compliance to the submission standards, procedures and policies in India

· Support Commercial Department in business development such as product evaluation and pre-launch activities

· Support Marketing/sales department for product review, product function training, catalogue preparation, content management, field queries resolution etc.

Qualifications

● More than 2 years of experience in technical documentation, regulatory affairs and quality assurance in the medical device industry

● Bachelor’s degree in relevant field. Master's is desirable

● Ethical behaviour and high level of integrity

● Good teamwork, independent and committed to works across functional department

● Possess good negotiation and dispute resolution skills

● Demonstrated experience operating in a regulated environment

● Ability to read, analyse and interpret governmental regulations & reports, scientific or clinical publications and data

● Ability to write reports, business correspondence, and quality procedures

● Must be able to effectively operate in a PC environment, be familiar with Microsoft Word, Excel, PowerPoint, Access, Outlook and Internet data search utilities

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