Lead - Regulatory Affairs
2 weeks ago
Title: Lead - Regulatory Affairs
Date: May 10, 2024 Location:Bangalore, KA, IN
We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that's bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out
What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it?
We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.
We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology.
If this excites you, then apply below.
Lead Regulatory Affairs
You will be responsible for :
Responsible for Regulatory intelligence dissemination and coordination, this includes
Identification of regulatory changes across all countries as applicable;
Impact assessment of the change;
Dissemination of regulatory changes along with the impact assessment to relevant stakeholders. Supporting Regulatory Information Management.
Responsible for Regulatory Assessment/Documentation, this includes
Gap analysis of the existing product technical documentation with respect to any changes in country-specific regulations.
Based on the gap analysis, update the product technical documentation for the change in country-specific regulation requirements and compilation for submission.
Responsible for registration support, this includes
Liasoning with local Authorized Representative (AR)/Local Distributor in each country.
Coordination for registration-related documentation submission & follow-up with Local AR/Distributor to ensure completeness of Technical documents.
Post submission, coordinate for query resolution, and ensure that the registration formalities are completed.
Perform gap assessment of EU MDD to EU MDR and remediation activities. Perform Technical file compilation.
Maintaining submission tracker.
Responsible for US FDA 510K technical dossier compilation & submission process-US FDA design files review and 510k documentation.
Team management – mentoring, guiding, planning and management of work, performance review and appraisal, conflict management, and training.
Leading cross-functional team meetings to update residual risk information for medical devices.
Timely delivery of deliverables with high quality.
Your impact:
About you:
Goal oriented, reliable, and extremely well organized with strong attention to detail
Demonstrates ability to work independently and work through projects with minimal supervision
Affinity with medical device regulations (21CFR), FDA Law, MDD, other global laws and regulations is a plus
Familiarity with preparation and submission of 510 (k) , PMA or international documents or registration and marketing of medical devices worldwide is a plus.
Proficiency with MS Office package
Proficiency with virtual collaboration tools (SharePoint, MS Team, Zoom, etc.)
Excellent technical & med device product documentation skills
Excellent English oral and written communication skills
Must have:
Bachelor's or master's degree in engineering/life science;
Overall experience: 7-10 years
Minimum 3-year experience with Medical Devices Regulatory Affairs or Q&C/R&D
Minimum 3-year experience in respective area of expertise
Minimum 1-year experience leading projects/teams
EQUAL OPPORTUNITY
Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate's merit and qualification.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
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