Senior Regulatory Affairs Specialist jobs at Philips in India, Pune

Your role:

• Developing and executing the regulatory strategy for new product development, design changes and field safety corrections for US, EU, Canada and RoW.
• Participate in strategic product development, design solutions from the concept phase to the product delivery phase and provide regulatory guidance throughout design and development.
• Responsible for product registrations/approvals for their responsible products within IGT-S portfolio.
• Author and lead 510(k) submissions, pre-sub meetings, EU MDR Technical Documentation, and Health Canada license applications. Lead interactions with regulators/competent authorities throughout the review and approval process.
• Review and validate labelling, marketing materials, claims substantiation evidence, clinical protocols to maintain compliance with global requirements.
• Keep abreast of current regulatory procedures and changes.
• Provide critical input and guidance on regulatory change assessments, risk assessments and regulatory requirements implementation.
• Participate in internal audits and play a key role in (external) audits, related to product submission such as FDA, MFDS, NMPA etc. and notified body audits.
• Lead and enable strong cross-functional partnerships between Regulatory Affairs and all key stakeholders, including R&D, Marketing, Quality, Clinical Affairs and other functions at all levels within the Business Unit.
• Identify areas for improvement in terms of efficiency and compliance for internal processes, work instructions, and forms and apply technical expertise to process improvement efforts. Lead and/or participate in process improvement teams to affect local or cross-business unit changes.
• Provide strategic guidance, mentor and coach the RA resources and project team by being a Regulatory subject matter expert.
• Establishes operational objectives and work plans.
• Work according to the business applicable processes and as ambassador of the Philips values.

(4 x bullets max)
1. Experience- Minimum of 7 years relevant working experience in medical device to regulatory strategy development supporting submissions and product market introductions (required)
2. Skills- Regulatory affairs, 510K, De Novo, PMA, and registrations of medical devices globally (including India) is highly preferred, dossier Preparation
3. Education- Bachelors/Master of Science degree
4. Anything else-

Project planning and management skills (preferred)

Excellent verbal, written communication skills (English) & interpersonal skills.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .

You will sustain and maintain labeling system software, hardware and processes in a medical device manufacturing environment.

Your role:

• Develop and maintain a complete labeling system (software, processes and equipment) for complex medical devices.

• You are responsible for: the development sustaining of a complete labeling system solution software; the quality and compliance of medical device labeling; internal and external database management; validation activities (software and hardware); and departmental work instructions/processes.

• Deployment and administration of a complete labeling system, including documented Work Instructions (WIs) and departmental Standard Operating Procedures (SOPs).

• Ensuring timely change management of labeling and Instructions For Use (IFUs), working with labeling technicians/label coordinators, and performing labeling changes.

• Quality management and all life-cycle phases of product labeling and IFUs. Leadership, both direct and indirect, will be an expectation of this role as a growth path.

You're the right fit if:

• You’ve acquired 1+ year of engineering experience in medical device or other highly regulated industry.
  Your skills include supporting quality related investigations and changes involving labeling materials and/or labeling processes, such as NCRs, CAPA, SICRs, IIAs, Audit Support questions, Equipment Events, Regulatory Gap Assessments, etc.

• You have a B.S. in Engineering.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

• You’re an excellent communicator that is detail oriented and well organized.

How we work together:

This is an office-based role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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The pay range for this position in CO is $71,250 to $114,000

Additional Information:

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Plymouth, MN .

As a Senior Hardware Engineer for high-volume consumer medical devices, you should be capable of architecting, designing, documenting, and implementing high-quality electronics on multiple platforms across multiple product ranges.

• This includes but is not limited to:

  • Hardware development using 8-bit micro-controllers up to 32-bit microcontrollers, battery charging circuits, and BLE radios.

  • Document, manage, and help to define/obtain/refine requirements, design docs, design reviews, and verification procedures,

  • Help establish consistent ways of working with respect to embedded system electronics/software/firmware.

  Requirements:

  • Degree in Electrical or Electronics Engineering.8+ years of experience in electronics hardware development in a professional organization, ideally in the Medical Device industry.

  • Hands-on knowledge of small micro-controllers and analog interfaces.

  • Mastery of oscilloscopes, function generators, power supplies, IDE’s and emulators for debugging and test.

  • Technical leadership skills in a multi-discipline engineering project environment.

  • Understanding of board and system-level technologies and the ability to read, interpret and review analog and digital circuit schematics.

  • Experience with electronics simulation tools such as PSpice.

  • Experience in wireless technologies such as BLE, Wi-Fi, Zigbee, etc.

  Desirable:

  • Experience in a regulated industry (FDA strongly preferred).

  • Six Sigma Black Belt certification.

  • Experience with Altium and Mentor Graphics tools for PCBA design.

  • Experience in defining, designing, documenting, testing, and implementing embedded firmware for 8-bit up to 32-bit microcontrollers using C.

  • Basic concepts of system architecture, systems engineering, and model-based design.

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Senior Engineering Manager

Experienced Senior Engineering Manager to lead our R&D X-ray Image Chain (Detectors, Grids, Collimator, Tubes and Generators etc.) team and oversee our Norm Compliance Officers. This dual role requires a blend of technical acumen and people leadership to ensure the successful development and compliance of our diagnostic X-ray systems.

Engineering Management

• Lead and mentor the R&D Image Chain Components (flat panel X-ray detectors, anti-scatter grids, generators, collimators and tubes)

• Oversee pre-development, product introductions, and lifecycle management of Image Chain Components.

• Manage Image Chain components road mapping in collaboration with external suppliers & releases with an international, cross-functional team.

• Coordinate technical investigations into customer complaints.

• Supervise Image chain advanced development activities.

• Ensure product quality through thorough tests and requirements engineering.

• Collaborate on software development projects.

Norm Compliance Leadership

• Review product requirements related to safety, EMC, and environmental standards like IEC, EN, and ISO.

• Oversee compliance test plans, including standards such as IEC60601 series and ISO 10993.

• Oversee risk assessment and mitigation for product safety.

• Support usability and software teams in creating certification documentation.

• Ensure third-party component compliance and liaise with certification agencies (like TUV/CSA).

• Oversee technical file deliverables for MDD, MDR, RED, REACH, and RoHS regulations.

• Support audits and regulatory submissions (FDA, Notified Body, INMETRO).

• Maintain DXR compliance lab qualifications according to ISO17025.

• Train and guide cross-functional teams on regulatory standards and compliance execution.

• Stay updated on regulatory changes and timely closure of standards gap assessments.

Job Knowledge, Skills and Experience:

• Educational Background : BE, BTech, ME, or MTech degree, preferably in Biomedical, Electrical, Electronics, or Instrumentation.

Experience:

• Minimum 15 years in R&D and engineering roles, with 3 to 5 years in System Engineering (preferably in product safety and norm compliance)

• Minimum 3 years of people management experience

Technical Skills:

• Medical device design and development experience in imaging modalities (like X-Ray, CT, MRI, Ultrasound)

• System Engineering - preferred experience with Image Chain/Acquisition, product safety and compliance

• Proficiency in regulatory submissions and relevant compliance standards (e.g., CE Marking, FDA, Health Canada).

• Preferred experience in product design and managing compliance documentation.

• Preferred familiarity with IEC62304, ISO14971, IEC60601 series and ISO 10993

Leadership Skills:

• Proven leadership and mentoring abilities.

• Strong problem-solving and project management skills.

• Excellent communication and stakeholder management capabilities.

• Ability to train and develop team members on compliance and regulatory standards.

Personal Traits:

• Detail-oriented with high ethical standards.

• Adaptability to regulatory changes and proactive learning approach.

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Job Title

Job Description

The primary function within this role is to execute Manufacturing Engineering activities through the course of high-quality process Verification & Validation activities.

In this role you are responsible to sustain and improve processes, tools and equipment of the Manufacturing systems, to ensure predictable, reliable, stable and efficient production processes. Supporting troubleshooting activities. Catcher of new product industrialization projects and manufacturing transfers for the site.

You will be responsible for driving meaningful and innovative Process Validation and suggesting in improving the process and support in Process Verification , Validation , IQ,OQ,PQ to improve quality and reduce cost, as well as performing the role of a technical lead in taking the product development through manufacturing release while transferring products from Engineering to Manufacturing and manage sustaining of different devices by following PDLM-MLD process.

In this role, you will be responsible for supporting Philips business like MRI, RF, IGT, SR&C DXR etc, you will ensure that all processes are capable to deliver consistent output as per-defined specification & consistent with the higher-level requirements

You are responsible for

• Is catcher of PDLM subprojects from Product Industrialization Engineer for a specific technology
• To follow the good manufacturing practices (GMP) .
• comprehension of DMR translation to production processes.
• Provides input for Manufacturing requirements in PDLM.
• To guide and perform PV related tests (e.g TMV, IQ, OQ & PQ) on the shop floor.
• Creates Quality Control Plan and Work Instructions
• Oversees equipment installation and supports ramp up of specific processes at the site
• May execute equipment installation and supports ramp-up of specific processes at the site
• Supports implementation of design changes
• Execute improvements in manufacturing processes, tools and equipment. This is for quality and efficiency improvements.
• Applies lean manufacturing principles
• Employs equipment, practices, and procedures which promote a healthy, safe, and secure work environment
• Executes the processes and standards with embedded quality into the way of working including adherence to compliance with safety, Cost regulatory- and environmental requirements as well as local laws, Philips General Business principles and other policies.
• Initiates and oversees process technology development activities in the context of New Product Generation as well as product and solution technology roadmap.
• Ensures adherence to the applicable process for product introductions, qualifications and release
• Responsible for Manufacturing input in PDLM process focusing on DfMAT
• Can lead & support quality-related problem-solving and root cause analysis during design and manufacturing
• Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers, or design teams) and initiates field actions when required
• Oversees equipment installation and supports ramp up of specific processes at the site
• Gives input from factory side to the sign-off at SR milestone & project close Implements
• Lead, prepare, and participate/be the main escort in internal and external audits
• Frequently interacts with supervisors and functional peer groups. Interaction normally requires the ability to gain the cooperation of others, conducting presentations of technical information concerning specific projects or schedules.
• Review/leadership for control of nonconforming products (QNs/MRB), including risk assessments.
• Review/leadership for product nonconformance investigation activities.
• Review/leadership for DEFOAs.
• Review/leadership for receiving inspection plans (RIPS)
• Review/leadership for Process Validation protocols and reports.
• Review/leadership for CAPA investigation activities
• Review/leadership for design/process changes (ECO/CRB)
• Assists, produces and completes STET Quality & Process Engineering related activities and documentation under direct supervision.
• Assists in ensuring that STET project supplier components / products (including spare parts and services) are released according to agreed specifications and APQP – PSW quality requirements.
• Assists in the support of CoNQ projects, and project management in the effective and timely risk
• Support of Regulatory agency audits and inspections in areas of responsibility.
• Review/leadership relating to accurate recordkeeping (GDPs) • Interface with cross-functional teams to ensure compliance and timely product releases
• Applies lean manufacturing principles

You are a part of

We work directly with our cross-functional and cross-discipline partners, including marketing, clinical specialists, service personnel and R&D, to deliver solutions through the execution of PDLM, Lifecycle, and Solutions Processes, with deliveries that exceed our customers' expectations.

• To succeed in this role, you should have the following skills and experience.
• Bachelor’s or master’s degree in production, mechanical, Electrical, Electronics engineering with 4-7 years’ experience.
• Strong quality assurance management experience, minimum 5 years in quality assurance
• Strong design control and new product development experience
• Strong analytical abilities
• Experience in CAD and PLM software’s
• Professional knowledge in ISO 13485, FDA 820, ISO14971, FDA/MDR/MDSAP
• Knowledge of FDA and IEC Standards is a plus.
• Disciplined team worker, ability to work independently.
• Ability to present ideas and to convince project team members.
• Be structured and self-organized.
• Positive ‘can do’ attitude.
• Quality mindset in analysis and documentation
• Excellent communication, both verbal and written
• Preferably already verification or validation background/ experience
• Design for 6 sigma / DMAIC is preferred
• Design for manufacturing, assembly and testability.
• Understanding special Process like Brazing, Soldering, Cleaning will be added advantage
• Basic regulatory understanding about ISO 13485, ISO 14971 will be added advantages
• Supportive in CAPA analysis
• A background in Data Analytics will be preferred.
• Integrated Supply Chain Management
• Capable to solve complex mfg. process Problem.
• Master data management (system) change Management
• He/ She should be good at Logistics Fundamentals, Manufacturing Fundamentals, Master data management (system), Operational Excellence, Operational Risk
• PMI Competencies (Project Management) or Certification will be added advantage
• Good Knowledge about Procurement & Sourcing Fundamentals
• Product Innovation & Lifecycle
• Capable of working independently in software tools Windchill, Minitab & SAP.
• Hands-on experience on performing Process Validations, Test Method Validations and MSA Studies (Process capability studies).

In return, we offer you.

• A rewarding career in Philips with an attractive package.
• An extensive set of tools to drive your career, such as a personal development budget, training, and coaching.
• Attractive collective health insurance package
• Opportunity to buy Philips shares and products with discount.