Job Location: Gurgaon
Overall Purpose: Regulatory and quality compliance for the entire Johnson & Johnson Medical franchise in India and IB Countries (Sri Lanka, Bangladesh, Maldives, Nepal & Bhutan). To maintain the life cycle management of the products registered by Johnson & Johnson. Develop regulatory strategies along with internal stakeholders to coordinate and mitigate interdependencies of overlapping projects to successfully submit applications to HA, averting any business impact. Ensure compliance with regulatory agency regulations and interpretations.
Essential Duties and Responsibilities:
Perform regulatory impact analysis of the changes occurring at the manufacturer level for products and production sites and act accordingly to ensure compliance with regulations through applicable submissions.
Organize and coordinate with stakeholders to conduct training sessions and attend applicable training sessions.
Review and approve product labeling to ensure compliance with regulations.
Identify and develop RA staff by making accurate assessments of individual capabilities and performance, providing feedback, coaching, guidance, and mentoring.
Participate and contribute in various technical committees of Medical Devices (MHD) conducted by the Bureau of Indian Standards (BIS) to ensure compliance with standards.
Assist in the development of work instructions and SOPs to streamline internal regulatory processes and ensure adherence to the same.
Proactive communications with stakeholders to develop trust, personal brand, and keep them updated about new regulations.
Interface with cross-functional teams such as marketing, planning, and supply chain to devise internal strategies for regulatory submissions.
Create and submit other regulatory submissions such as query responses, corrections filings, adverse/serious adverse event reporting, and miscellaneous notifications regarding post-registration changes to maintain the regulatory life cycle of products for India, ASPAC, Sri Lanka, and Bangladesh market in accordance with applicable regulations and guidelines.
Support with on-time inputs for monthly regulatory reports.
Other assignments identified and assigned by Supervisor/Management from time to time.
Qualifications Requirements:
Strong knowledge of Medical Device Rules.
Strong knowledge of Medical Device guidelines for Sri Lanka and Bangladesh.
Knowledge of international regulations of Medical Devices in the US and EU.
Sound knowledge of Medical Device Quality Management System ISO.
Excellent proficiency with software tools.
Graduate/Post Graduate in Life Science/Bio Medical/Pharmacy.
Minimum 5-8 years of industry experience in Regulatory Affairs, preferably in medical devices.
Sound understanding of MD regulations in India.
Experience of submitting, registering, and maintaining product registrations with MOH.
Experience in quality/manufacturing and regulatory affairs in medical devices would be an advantage.
Experience in assembling product dossiers for submission to Regulatory Authorities.
Good technical writing and communication skills.
Strong team leadership experience and motivational skills.
Advanced computer skills specifically in MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
Core Competencies Required for This Role:
Translate insights into innovative and viable products or solutions that create value.
Challenge the status quo; lead and adapt to change.
Take and properly manage risks.
Take ownership for and/or support talent acquisition, performance, and development of self and others.
Leverage diverse perspectives, backgrounds, and talent.
Engage in transparent and constructive conversations.
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