
Program Manager, Regulatory Affairs
5 days ago
Program Manager, Regulatory Affairs, Maternal Infant Care
Job Description SummaryProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the marketGE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description
Roles and Responsibilities
-
Provides regulatory strategy and direction for the MIC business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally.
-
Prepares global regulatory submissions by working across the regulatory organization and cross functionally with other functions such as Engineering, Clinical, and Scientific, and submits premarket submissions to regulatory authorities such as FDA, EU, NMPA, PMDA, MFDS, CDSCO, etc., as per business' timelines.
-
Assesses changes in existing products and determines the need for new / revised licenses or registrations.
-
Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
-
Is an active member of external industry trade associations and/or standards organization and/or other relevant external groups to help shape regulatory requirements.
-
Proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.
Required Qualifications
-
Bachelor's degree in a Scientific, Engineering, Computer Science, or other core Life Science discipline, or a combination of training and experience demonstrating the equivalent.
-
A minimum of 6 years combined work experience in heavily regulated fields such as medical devices, pharmaceuticals, or biologics.
-
A minimum of 5 years' experience in Regulatory Affairs.
-
A minimum of 5 years' experience in regulatory agency interactions and regulatory project management.
-
Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer's requirements.
-
Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and collaboration applications.
Desired Characteristics
-
Experience with Software (SiMD or SaMD), cybersecurity, and other non-device software products.
-
Experience with Biocompatibility standards and regulator expectations.
-
Experience with high risk, life supporting, and life-sustaining products.
-
Advanced degree in scientific, technology or regulatory affairs disciplines.
-
Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society (RAPS).
-
Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial, or political situations and their impact on GE Healthcare regulatory strategies.
-
Demonstrated life-long learner; eagerness to obtain new skills and knowledge.
-
Humility in understanding, but assertive when needed; willing to make decisions and assign clear priorities.
-
Proven track record of strong collaborative skills with key partners, such as engineering and commercial
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
Additional InformationRelocation Assistance Provided: No
-
Regulatory Affair Manager
5 days ago
Bengaluru, Karnataka, India Futura Surgicare Full time ₹ 20,00,000 - ₹ 25,00,000 per yearPosition Title: Regulatory Affairs & QA ManagerDepartment: Quality & Regulatory AffairsLocation: BangaloreRole OverviewThe Regulatory Affairs cum QA Manager will be responsible for ensuring compliance of medical devices with applicable international and local regulatory requirements, while also leading the Quality Management System (QMS) to meet ISO 13485,...
-
Regulatory Affairs Manager
1 week ago
Bengaluru, Karnataka, India ITC Full time ₹ 15,00,000 - ₹ 25,00,000 per yearRegulatory Affairs Manager ITC FoodsLocation: BangaloreExperience: 10+ yearsWe are looking for a seasoned Regulatory Affairs Manager to join our team at ITC Foods.Key Responsibilities:Lead regulatory compliance for food products across the US (FSMA, 21 CFR, USDA including NOP), EU, GCC and other international markets which includes Regulatory and Food Safety...
-
Regulatory Affairs Specialist
4 weeks ago
Bengaluru, Karnataka, India Biocon Biologics Full timePosition Summary The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...
-
Regulatory Affairs Specialist
7 days ago
Bengaluru, Karnataka, India Biocon Biologics Full time ₹ 9,00,000 - ₹ 12,00,000 per yearPosition SummaryThe Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...
-
API Regulatory Affairs
1 week ago
Bengaluru, Karnataka, India Biocon Ltd Full time ₹ 15,00,000 - ₹ 20,00,000 per yearRoleAPI Regulatory Affairs DMF Filing/ Compilation (Global market)Level Associate Manager / Manager Level:-Required Education/Exp :-Experience Req. : 11 yrs.18 yrs. Qualification:M.Sc. / M.PharmaResponsibilities1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc.2. Compilation and submission of DMFs...
-
Bengaluru, Karnataka, India GE HealthCare Full time ₹ 20,00,000 - ₹ 25,00,000 per yearJob Description SummaryProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. Has knowledge of best practices and how own area integrates with others; is...
-
Regulatory Affairs Executive
7 days ago
Bengaluru, Karnataka, India Invision Pharma Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per yearWe are looking for aRegulatory Affairs Executive/Food Regulatory & Compliance Serviceswith1–2 years of experiencein nutraceuticals or related industries. The candidate will be responsible for handling regulatory submissions, product approvals, and ensuring compliance with local and international guidelines for nutraceuticals and dietary supplements.Key...
-
Specialist - Regulatory Affairs Manager
7 days ago
Bengaluru, Karnataka, India Merck KGaA Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Id291311Bangalore, Karnataka, IndiaJob TypeFull-timeWork Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream...
-
Senior Regulatory Affairs Manager
7 days ago
Bengaluru, Karnataka, India Biocon Biologics Limited Full time US$ 90,000 - US$ 1,20,000 per yearJOB DESCRIPTIONWe are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.RESPONSIBILITIES:• Plan and manage development of high...
-
Regulatory affairs executive
3 weeks ago
Bengaluru, Karnataka, India Halma Plc Full timeAbout Halma:Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.Our diverse group of nearly 50 global companies specialise in market leading technologies that push the...