Senior Manager, Regulatory Affairs

Summary

Senior Regulatory Affairs Manager will play a pivotal role in ensuring that the company's medical devices and processes meet AERB regulatory requirements, thus safeguarding patient safety, compliance to regulatory requirements and facilitating market access.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. 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

Role and Responsibilities

Regulatory Compliance:

Stay informed about atomic energy regulations, guidelines, and standards related to radiation safety of medical devices.

Interpret and communicate regulatory requirements to cross-functional teams to ensure compliance throughout the product lifecycle.

Regulatory Strategy:

Provide strategic input to product development, manufacturing, refurbishment teams to ensure regulatory considerations are integrated early in the development/setup process.

enable Submission Management

Prepare, review, and submit regulatory documents to health authorities for product approvals, clearances, and registrations.

Manage interactions with AERB during the submission and review processes.

Quality Management System (QMS):

Enable the implementation and maintenance of an effective QMS that complies with regulatory requirements.

Enable internal and external audits related to regulatory affairs areas.

Ensure auditing of radiation performance and safety test reports are conducted as per plan and report outcomes to leadership team.

Post-Market Surveillance:

Establish and enable post-market surveillance processes to monitor and report radiation events other post-market activities.

Coordinate with relevant departments to implement corrective and preventive actions based issues and findings related to AERB requirements.

Cross-Functional Collaboration:

Collaborate with cross-functional teams, including R&D, clinical affairs, Service, manufacturing, and marketing, to ensure alignment with regulatory requirements.

Provide regulatory input in cross-functional meetings and projects.

Regulatory Intelligence:

Monitor changes in the regulatory landscape and provide updates on potential impacts to the organization.

Proactively identify emerging regulatory issues and recommend strategies for compliance.

Training and Education:

Provide training on regulatory requirements and updates to internal stakeholders.

Stay updated on industry trends and best practices and share this knowledge within the organization.

Risk Management:

Work closely with teams to assess and mitigate regulatory risks associated with product development and commercialization.

AERB related activities include but not limited to

Single point contact for commercial organization on AERB matters. Single point liaison with regulator on all matter related to licensing, inspection activities, resolving customer issues. Provide training and guidance on pre-sales, delivery, and post installation AERB requirements to commercial organization. Establish and execute compliance monitoring process for AERB requirements across commercial organization. Conduct field audits on QA testing activities to monitor and drive compliant execution. Manage compliance activities on procurement permission compliance across radiation emitting devices. Communicate new/ changing regulatory requirements. Drive implementation of new requirements as and when published/communicated by AERB. Enable digitization initiatives on AERB reports as and when planned. Co-ordinate and Collaborate with industry forums and regulators for advocacy matters. Manage BIS inspections related activities for ISO7620 compliance.

Required Qualification

Nuclear Medicine physicist, RSO Level III qualified per AERB requirements

Technical Experience

Experience in a regulated industry in QA / RA / Design / Manufacturing / similar functions.

Prior Experience of managing AERB supplier activities for radiation generating medical imaging devices and cyclotron

Lead and provide tactical guidance to teams.

Desired Skills

Ability to implement ISO standards / regulations effectively.

Able to identify and monitor for changes to requirements.

Applies several sets of requirements together balancing strategy effectively.

Ability to interpret changes in standards/regulation, environment, impact to QMS & communicate in a timely and effective manner.

Willingness and able to gather product knowledge as applicable to role.

Ability to understand, adhere to and follow procedures and guidelines, incl.GEHC QMS Processes, region specific regulatory linked QMS requirements.

Applies standard procedure and learned knowledge to develop compliance solutions within established guidelines - e.g., be able to read the standards and develop options based on product and organizational knowledge.

Self manages assigned deliverables without direct management.

Meets agreed upon timelines without frequent updates.

Ability to investigate and develop corrective actions for non-conformances arising by deviations, internal audit, or regulatory inspection.

Sees constraints early and highlight them to leadership for resolution.

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

Full time