דרושים Principal Compliance ב-Boston Scientific ב-India, Gurugram District

India-Haryana, Gurgaon

About Job Role:

Independently conducts development work as part of a major research and/or development project. Receives minimal technical direction/review on broad scope or complex projects. Viewed as an expert in one or more in-house technologies.

• Performs pioneering engineering work as part of major programs.
• Drives complex or novel assignment requiring the development of new or improved techniques and procedures. Work is expected to result in the development of new or refined technologies, products, materials, processes, equipment, and/or scientific method to broaden BSC's Intellectual Property in key strategic areas.
• Is acknowledged as a subject matter expert in a relevant technical field and influences associated site-wide technology planning.
• Is a significant contributor to operational performance improvement through identification and implementation of major CIP'S, application of advanced problem-solving techniques and access to a corporate-wide technical resource base.
• Successfully completes engineering work in one or more of the following: technology development, product design and development, test of materials, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
• Provides guidance to product and technology teams.
• Assesses the feasibility and soundness of alternative engineering processes, products, or equipment.
• Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
• Interfaces with Physicians/Cath Lab personnel to identify needs and to obtain feedback on concepts and performance of new devices and to translate customer needs into product concepts.
• Develops and coaches others on engineering documentation.
• Trains and/or provides work direction to technicians and less experienced engineers.
• Supports teamwork and staff development through a commitment to mentoring and technical leadership.
• Demonstrates thorough knowledge of manufacturing impact on product performance as perceived by the customer.
• Build Quality into all aspects of work by maintaining compliance to all quality requirements.

Education and Skill-Set Required:

• BE/B.Tech degree in Mechanical engineering
• Minimum 12 years of R&D / NPD experiences in medical devices
• Required to have experience in at least 2 complete product lifecycles i.e. from product conceptualization to design, development, and manufacturing of medical devices
• Knowledge in medical grade material sciences and processing – Metals, Polymers, plastics
• Should have knowledge of quality system & processes that needs to be applied for product development
• Project Management with proficiency in MS project or similar tools

India-Haryana, Gurgaon

About Job Role:

Independently conducts development work as part of a major research and/or development project. Receives minimal technical direction/review on broad scope or complex projects. Viewed as an expert in one or more in-house technologies.

• Performs pioneering engineering work as part of major programs.
• Drives complex or novel assignment requiring the development of new or improved techniques and procedures. Work is expected to result in the development of new or refined technologies, products, materials, processes, equipment, and/or scientific method to broaden BSC's Intellectual Property in key strategic areas.
• Is acknowledged as a subject matter expert in a relevant technical field and influences associated site-wide technology planning.
• Is a significant contributor to operational performance improvement through identification and implementation of major CIP'S, application of advanced problem-solving techniques and access to a corporate-wide technical resource base.
• Successfully completes engineering work in one or more of the following: technology development, product design and development, test of materials, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
• Provides guidance to product and technology teams.
• Assesses the feasibility and soundness of alternative engineering processes, products, or equipment.
• Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
• Interfaces with Physicians/Cath Lab personnel to identify needs and to obtain feedback on concepts and performance of new devices and to translate customer needs into product concepts.
• Develops and coaches others on engineering documentation.
• Trains and/or provides work direction to technicians and less experienced engineers.
• Supports teamwork and staff development through a commitment to mentoring and technical leadership.
• Demonstrates thorough knowledge of manufacturing impact on product performance as perceived by the customer.
• Build Quality into all aspects of work by maintaining compliance to all quality requirements.

Education and Skill-Set Required:

• BE/B.Tech degree in Mechanical engineering
• Minimum 12 years of R&D / NPD experiences in medical devices
• Required to have experience in at least 2 complete product lifecycles i.e. from product conceptualization to design, development, and manufacturing of medical devices
• Knowledge in medical grade material sciences and processing – Metals, Polymers, plastics
• Should have knowledge of quality system & processes that needs to be applied for product development
• Project Management with proficiency in MS project or similar tools

About the role: Principal, Compliance

Key responsibilities include overseeing local compliance through effective policies, risk management, due diligence, and training for employees and third parties. The role also involves reviewing and approving interactions with healthcare professionals and third parties, while conducting monitoring activities to minimize compliance risks and protect the company’s interests.

Compliance Advisory and Business Support

• Provides compliance guidance and advice to local commercial and functional teams, and pro-actively supports business matters to ensure compliance with corporate standards and mitigation of compliance risks. Acts as a local subject matter expert on all aspects of compliance program.
• Reviews and advises on matters and documents related to commercial activities, engagement of healthcare professionals, third parties & service providers, etc.

Compliance Program Development and Management

• Develop, implement, and maintain compliance program, policies, procedures, and processes to ensure adherence to internal standards, legal and compliance requirements, and industry best practices.

Compliance Incident Management

• Manages compliance incidents and deviations, escalating matters appropriately to the APAC Growth Markets Compliance team.

Compliance Training, Communication, and Culture Building

• Provide compliance training to business partners and other internal stakeholders and externally to third parties.
• Responsible to create and develop engaging communications for a wide audience that contribute to an enhanced culture of compliance at the Company.
• Lead efforts to foster a culture of integrity and ethical conduct within the organization by promoting compliance awareness at all levels.

Monitoring, Auditing, and Continuous Improvement

• Establish robust monitoring and auditing processes to evaluate the effectiveness of compliance controls and identify opportunities for improvement.
• Support and participate in internal and external audits, ensuring that all findings and observations are addressed in a timely and effective manner.

Regulatory Awareness and Compliance Management

• Stay informed of changes in laws, regulations, and industry trends to proactively address emerging compliance issues and implement necessary adjustments.

Others

• Lead strategic projects/initiatives for the compliance team.
• Perform other duties as assigned.

Your Experience:

• Bachelor’s degree or equivalent and a minimum of 10-14 years in compliance or related fields within the medical device, pharmaceutical, or healthcare industry. The candidate can also be from audit consulting firms managing healthcare-related work.
• Knowledge of FCPA/local anti-bribery laws; regulatory promotional practices.
• Proficiency in both written and spoken English and local language is essential for effective communication with team members.
• Strong leadership, communication, and interpersonal skills, with the ability to collaborate effectively and influence stakeholders across all levels of the organization.
• To proactively work on risk management strategy for the organization depending upon the changes in laws, policies, audit findings, etc.