Senior Regulatory Affairs Specialist

2 weeks ago

Pune, India Philips Full time
JOB DESCRIPTION

Job Title

Senior Regulatory Affairs Specialist

Job Description

Job title:

Senior Regulatory Affairs Specialist

Job Description:

The Senior Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW. Collaborate with the cross functional team (including R&D, design quality, marketing, supply chain etc.) to create submission contents. Lead 510(k) submission, preparation of EU MDR Technical Documentation, Health Canada license applications and other global registrations and work with global regulators/competent authorities throughout review and approval process. Supports activities required to maintain regulatory compliance as new or revised versions of standards, guidance documents are published. Monitor global regulatory landscapes and supports implementation of regulation changes and executes quality plans to minimize business impact. Provides Regulatory assessment of product changes for launch and sustaining activities. Review labelling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements. Identify areas for improvement for efficiency and compliance in internal processes, work instructions, and forms and apply technical expertise to process improvement efforts. May lead or participate in process improvement teams to affect changes at a local or cross business unit level.

Job Requirements/Qualifications:

Minimum of 10+yrs years of experience in the medical device industry with regulatory submission experience. 510(k) submission experience preferred. Minimum of a bachelor’s degree in engineering or a related scientific field. Degree within Regulatory Affairs and/or Regulatory Affairs Certification is preferred. Proficiency in understanding, interpretation, and the application of FDA 21 CFR 820 Quality System Regulations, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations. Prior experience supporting/leading regulatory submissions such as 510k, EU MDR Technical Documentation and global registrations Strong written, oral, and interpersonal communication skills to be able to work in a team environment. Solution and detail oriented, well organized and self-motivated.



About Philips
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.
• Learn more about .
• Discover .
• Learn more about .

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 commitment to diversity and inclusion .

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Pune, India Philips Full time

    Job TitleSenior Regulatory Affairs SpecialistJob DescriptionJob title:Senior Regulatory Affairs SpecialistJob Description:The Senior Regulatory Specialist will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW.Collaborate with the cross functional team (including R&D,...

  • Regulatory Affairs

    3 months ago

    Pune, India Statistical Pharma Full time

    The **Regulatory Affairs Specialist** stays with the same company for an average of 10 to 15 years; the rate of turnaround is therefore low. Networking is very much encouraged, through joining various associations to participate in conferences and exhibitions, and also to access current literature. Presently, there is a strong demand for Regulatory Affairs...

  • Specialist – Regulatory Affairs

    4 weeks ago

    Pune, India BYK India Private Limited Full time

    Specialist – Regulatory Affairs Location: Pune Responsibilities The position focuses on functions in regulatory affairs with a centring on tariff classification of BYK products, analyzing products with regard to prohibited substances, execution of European product applications with the help of SAP and opesus (UFI code) as well as...

  • Regulatory Affairs Principal Specialist

    2 weeks ago

    Pune, India Philips Full time

    JOB DESCRIPTION Job Title Regulatory Affairs Principal Specialist Job Description Regulatory Affairs Principal Specialist The Principal Regulatory Specialist will work within our Sleep & Respiratory Care business group (SRC) on home and hospital respiratory care products. This may include ventilators, oxygenators, and other accessories. The role...

  • Regulatory Affairs Principal Specialist

    2 weeks ago

    Pune, India Philips Full time

    Job TitleRegulatory Affairs Principal SpecialistJob DescriptionRegulatory Affairs Principal SpecialistThe Principal Regulatory Specialist will work within our Sleep & Respiratory Care business group (SRC) on home and hospital respiratory care products.  This may include ventilators, oxygenators, and other accessories.  The role will provide day to day...

  • Drug Regulatory Affairs

    3 months ago

    Pune, India Statistical Pharma Full time

    **Regulatory Affairs Specialist duties and responsibilities** - Ensuring compliance with all regulatory requirements - Maintaining regulatory documentation database - Assisting with the preparation and submission of all regulatory reports - Providing accurate reviews of data and reports - Ensuring accurate and timely submissions to regulatory agencies -...

  • Regulatory Affairs Executive

    3 months ago

    Pune, Maharashtra, India Statistical Pharma Full time

    The role and function of a Regulatory Affairs Officer includes the following duties and responsibilities: - Preparing submissions of licence variations and renewals to strict deadlines; - Ensuring that a company’s products comply with regulations; - Keeping abreast of international legislation, guidelines and customer practices in all countries that the...

  • Regulatory Affairs Officer

    3 months ago

    Manjri, Pune, Maharashtra, India Fusion Market Research Full time

    _**Duties/Responsibilities**:_ - Works in the regulatory affairs department on assigned projects. - Coordinates with product development and/or research and development teams to request, develop, and prepare required data and reports to be submitted to regulatory bodies and agencies. - Collaborates with key staff from Planning, Product Development,...

  • Senior Manager, CMC Facilities Regulatory Affairs

    4 months ago

    Pune, India 9627 Corixa Corporation Full time

    At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...

  • Regulatory Affairs Executive

    4 months ago

    Pune, Maharashtra, India Nissar Transformers Pvt Ltd Full time

    Position - Regulatory Affairs (RA) Executive Location - pirangut Experience - 1 to 3 yrs **Responsibilities**: Strategy & Planning: Develop regulatory strategies for product approvals. Guide project teams on regulatory needs. Submissions: Prepare and submit regulatory documents (e.g., INDs, NDAs). Ensure timely and accurate...

  • Specialist, Regulatory

    4 months ago

    Pune, India Avient Full time

    Job Summary : The Regulatory Specialist operates within the Product Stewardship team who are responsible for managing all regulatory matters for the global business, liaising with all global company locations and customers in Europe, Asia, North America and Latin America.The Regulatory Specialist will support in the development, implementation and...

  • Director, Global Regulatory Affairs, Vaccines

    3 months ago

    pune, India 9627 Corixa Corporation Full time

    Are you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a Director, Regulatory Affairs, Vaccines you will ensure the development and...

  • Director, Global Regulatory Affairs, Vaccines

    3 months ago

    Pune, India 9627 Corixa Corporation Full time

    Are you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a Director, Regulatory Affairs, Vaccines you will ensure the development and...

  • Director, Global Regulatory Affairs, Vaccines

    11 hours ago

    pune, India 9627 Corixa Corporation Full time

    Are you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a Director, Regulatory Affairs, Vaccines you will ensure the development and...

  • Regulatory Affairs

    7 days ago

    Pune, Maharashtra, India Kelly Services Internal Full time

    **Job Title**: Regulatory Affairs Engineer **Locations**: Pune, India **Job Description**: - **A Bachelor’s degree or higher in a technical field, health /Medical sciences or related.**: - **Mandatory Background in the global medical devices Regulationindustry would be considered a strong plus.**: - **Good knowledge on International regulation,...

  • Regulatory Affairs Executive

    3 months ago

    Balaji Nagar, Pune, Maharashtra, India Vertex Business Solutions Full time

    Regulatory Affairs Executive act as a link between companies and regulatory authorities, ensuring that products are manufactured, tested and distributed in compliance with appropriate legislation. **Responsibilities**: - studying scientific and legal documents to check they meet legal requirements. - Gathering, evaluating, organising, managing and...

  • Global Regulatory Affairs Director

    3 months ago

    pune, India 9627 Corixa Corporation Full time

    At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...

  • Global Regulatory Affairs Director

    12 hours ago

    pune, India 9627 Corixa Corporation Full time

    At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...

  • Global Regulatory Affairs Director

    3 months ago

    Pune, India 9627 Corixa Corporation Full time

    At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...

  • Senior Regulatory Publisher

    2 weeks ago

    pune, India TransPerfect Full time

    OVERVIEWThe Senior Regulatory Publisher is responsible for working with Regulatory Affairs to publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standards, as well as to prepare, assemble and submit applications (IND/CTA/NDA/MAA/NDA, etc.) for...