Regulatory Affairs Specialist

Date: Oct 8, 2021

Location: Mumbai, IN

Company: Carestream Health

Position Summary:

Acts on behalf of Carestream Health Inc. representing products in an assigned portfolio, in assigned region or clusters and works with country distributors and regional Sales Managers to achieve product clearance. Works with country Ministry of Health, other regulators and/or trade associations to assure accurate compliance interpretations are obtained, and to influence decisions, where appropriate.

Position Responsibilities:

•    Work closely with the Regulatory Affairs team to establish and implement corporate regulatory policies and procedures to assure compliance with applicable international regulations and standards.
•    Supply regulatory expertise to Sales Managers to help support effective business plans.
•    Work with internal Regulatory Affairs resources, external distributors, and external consultants to obtain Ministry of Health agency product registration/licenses requirements.
•    Monitor and communicate changes to medical device products laws, standards, guidance, etc.
•    Provide guidance on compliance requirements to obtain marketing approval for products.
•    Prepare dossiers for product registrations/approvals.
•    Submit dossiers and provide Regulatory Affairs support/coordination for product registrations/approvals and ensure registrations in line with business time and cost requirements.
•    Maintain documentation system to assure all internal associates (regulatory, sales, marketing, etc.) have access to up-to-date registration/license documents
•    Manage external services such as third-party agencies and product test houses.
•    Lead Vigilance/Post-Market activities, under the direction of Corporate Regulatory Affairs Post-Market Managers.
•    Support/coordinate obtention of product wireless licenses.
•    Answer questions and enquires from distributors for regulatory evidence requests.
•    Assist in training on device regulations for regulated products.

Required Skills & Education:

•    Graduate in relevant stream (Business or Engineering Education)

•    Min 5-8 yrs of experience in Regulatory Affairs for the respective Regions (EMEA and APAC, for medical devices industry)
•    Experience of registration leadership for the assigned territory
•    Relevant ISO/QMS qualification is preferred, along with knowledge of AERB, BIS requirements
•    Fluent in English, second language(s) for assigned territory is a plus
•    Technical understanding of products, radiology and digital
•    Proven Project Management skills
•    Good organizational/planning skills
•    Ability to provide accurate advice to all levels within the company
•    Good level of IT skills
•    Attention to detail
•    Excellent interpersonal skills and strong virtual/remote communication skills

Desired Skills:

•    Leadership in driving internal and external processes
•    Must follow through
•    Must have sense of urgency
•    Must be able to recognize and plan/set priorities
•    Close teamwork to Regulatory Affairs, Sales and Service
•    Customer service oriented
•    Team player