Current jobs related to Program Manager, Regulatory Affairs, Maternal Infant Care - INDBengaluruEPIP Phase II - GE HealthCare

  • Senior Engineering Manager

    2 weeks ago

    IND--Bengaluru-EPIP (Phase II), India GE HealthCare Full time

    Job Description SummaryWe are seeking a technically strong, strategic Engineering Manager to lead a software team in the Maternal and Infant Care (MIC) Engineering organization. As Functional Manager, you will guide your team through advanced software design, development, integration, and product delivery for MIC products.You will align technical execution...

  • Regulatory Affairs

    4 days ago

    Bengaluru, Karnataka, India UST Full time

    Role DescriptionJob Title: Regulatory Affairs Associate – Authoring.Role detailed classificationRegulatory Affairs AuthoringJob Summary: We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Associate – Authoring to join our LS Practice team. The successful candidate will be responsible for LS Regulatory Authoring...

  • Lead Regulatory Affairs Specialist

    6 days ago

    IND Bengaluru - Technology Campus, India BD Full time

    Job Description SummaryThis position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. This position participates on cross-functional teams, leads the development of global regulatory strategies, authors regulatory submissions, interacts with regulatory agencies/notifiedbodies, reviews design...

  • Regulatory Affairs Associate

    4 weeks ago

    Bengaluru, India ANRGI TECH Pvt. Ltd. Full time

    Job Description Job Title: Regulatory Affairs Associate – Authoring.  Role detailed classification Regulatory Affairs Authoring Job Summary: We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Associate – Authoring to join our LS Practice team. The successful candidate will be responsible for LS Regulatory Authoring...

  • Regulatory Affairs Associate

    4 weeks ago

    Bengaluru, India ANRGI TECH Pvt. Ltd. Full time

    Job Title: Regulatory Affairs Associate – Authoring.  Role detailed classification Regulatory Affairs Authoring Job Summary: We are seeking highly skilled and experienced Life Sciences (LS) Regulatory Affairs (RA) Associate – Authoring to join our LS Practice team. The successful candidate will be responsible for LS Regulatory Authoring and/or other...

  • Senior Associate

    1 week ago

    Bengaluru, India ClinChoice Full time

    Job Description Job Title: Senior Associate Regulatory Affairs Employment Type: Full time Location: Bengaluru/Hyderabad, India About ClinChoice ClinChoice partners with many of the world's leading pharmaceutical, medical device, and consumer care innovators. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs,...

  • Manager - Regulatory Affairs

    6 days ago

    Bengaluru, Karnataka, India Aarna HR Solutions Full time

    Company Description Greeting Aarna HR Solutions is a Human Resource Recruitment Company providing services to Various IT, ITES and Non- IT companies across India. Aarna Solutions strive towards hiring the best and the brightest talent in the industry. We hire individuals with a strong sense of pride in their performance, team spirit, and a desire to excel. ...

  • Director - Program Management

    6 days ago

    IND--Bengaluru-EPIP (Phase II), India GE HealthCare Full time

    Job Description SummaryDevelops, implements, and maintains robust project management mechanisms and processes to ensure consistent and efficient program execution in Value CT. Drives initiatives to improve the effectiveness of the Engineering function and interfaces with other functions to provide effective coordination of metrics, dashboards, functional...

  • Senior Staff Technical Program Manager

    4 days ago

    IND--Bengaluru-EPIP (Phase II), India GE HealthCare Full time

    Job Description SummaryAs part of the Imaging System Software team at GE HealthCare, you will be responsible for wing-to-wing execution and delivery of complex platform programs across the different Imaging modalities in line with the roadmap of the GE Healthcare Imaging business. This role requires you to work closely with technical teams and global...

  • regulatory affairs

    1 week ago

    bengaluru, India Randstad Full time

     What do we offer you? Competitive salary and benefits packageRemote work opportunitiesProfessional development and growth opportunitiesCollaborative and supportive team environmentChance to make a significant impact on a global scaleWork-life balance Who are you?We are looking for a dedicated and experienced Regulatory Affairs Specialist to join our...

Program Manager, Regulatory Affairs, Maternal Infant Care

2 weeks ago

INDBengaluruEPIP Phase II, India GE HealthCare Full time ₹ 8,00,000 - ₹ 24,00,000 per year
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 market

GE 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 Information

Relocation Assistance Provided: No