Senior Regulatory Compliance Specialist

16 hours ago

Ahmedabad, Gujarat, India beBeeRegulatory Full time US$ 80,000 - US$ 1,20,000

Job Title: Regulatory Affairs Specialist

Job Description:

  • We are seeking an experienced candidate 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.
  • The successful candidate will be responsible for 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.
  • Responsibilities will also include preparing responses against 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 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 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 labeling 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 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

Required Skills & Qualifications:

  • More than 2 years of experience in technical documentation, regulatory affairs and quality assurance in the medical device industry.
  • Bachelors degree in relevant field. Masters is desirable.
  • Ethical behaviour and high level of integrity.
  • Good teamwork, independent and committed to work across functional departments.
  • 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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