Regulatory Affairs Analyst
1 hour ago
Varex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the following:Job Description- Keeps abreast of medical device regulatory procedures, medical device safety standards and changes in global regulations.- Strong working knowledge of FDA regulations, UK, EU, ISO13485, Brazil, Australia, China, Japan, Canada, and Rest of World- Compiles all materials required in submissions, license renewal and annual registrations to FDA, Health Canada, China NMPA, and other international authorities.- Supports global product registrations, including the compilation and maintenance of regulatory dossiers, technical documentation, and country-specific submission materials.- Performs device classification assessments in accordance with regulatory frameworks in the U.S., Canada, EU, China, and other global markets- Maintains strong understanding of country-specific documentation and regulatory expectations for product submissions, compliance, and import/export.- Prepares and provides Certificates of Compliance, Declarations of Conformity, and other supporting compliance documents for internal and external stakeholders.- Participates in post-market surveillance, GMP compliance, 3rd party audits, inspections, reviews and approves advertising and promotions materials.- Recommends changes for labeling, manufacturing, marketing, and usability protocols for medical device regulatory compliance.- Participate as team member to plan, develop, and implement regulatory strategy throughout the medical device product lifecycle.- Reviews and approves design outputs.- Uses regulatory information and knowledge to integrate regulatory perspectives into the organization, its policies, and procedures.- Reviews, approves, and recommends changes for labeling, manufacturing, marketing, and test protocols for regulatory compliance and/or approval.Required Skills and Experiences- Bachelor’s Degree in life sciences, engineering, regulatory compliance,- 2+ years of experience in regulatory compliance in the medical device industry and medical device safety standards.- 2+ years of experience driving related medical device safety standards into design requirements.- 2+ years of experience completing multiple submissions across health authorities.- Experience with Class I, II, and/or III medical devices and industrial products (including experience determining device classifications globally).- Proven track record of preparing and managing regulatory submissions (e.g., FDA 510(k), Health Canada License Applications, EU Technical Files, NMPA dossiers, etc.).- Experience supporting product registrations and certifications across multiple international markets.- Microsoft Office/ERP/QMS Software competencyWhat we offer- A unique opportunity to become part of growing organization in India being part of a global market leader in Xray imaging components.- Excellent development potential- An international work environment with global teams collaborating on various projects across several countries.- Competitive compensation package including participation in Varex incentive plans- Corporate Health Benefits- Additional benefits will be added as we grow
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Regulatory Affairs Analyst
6 days ago
Pune, Maharashtra, India Varex Imaging Corporation Full time ₹ 4,00,000 - ₹ 12,00,000 per yearTo apply to a Varex Imaging position, please create an account and sign-in.CURRENT VAREX IMAGING EMPLOYEES: Please apply by logging into your internal Workday Account.SummaryVarex Imaging Regulatory Affairs Analyst participates in the compliance of medical and industrial x-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional...
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Regulatory affairs analyst
3 hours ago
Pune, India Varex Imaging Corporation Full timeVarex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the...
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Regulatory Affairs Analyst
10 minutes ago
Pune, India Varex Imaging Corporation Full timeVarex Imaging Regulatory Affairs Analyst participates in ensuring compliance of medical and industrial X-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional team that includes Engineering, Manufacturing, Sales, Marketing, Quality and Customers. In addition, the regulatory affairs analyst is expected to perform the following:...
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Pune, India Whatjobs IN C2 Full timeDear Candidate, We are hiring for the Regulatory Affairs role-handling the below job responsibilities, Job Title: Regulatory Affairs Manager Company: Brinton Pharmaceuticals Ltd. Location: Kharadi, Pune Salary: Best in Industry Joining: Immediately Job Description: Regulatory Affairs Manager Position Overview: We are seeking an experienced and resourceful...
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Pune, Maharashtra, India Batavia Pharma Pvt Ltd Full timeRole & responsibilitiesRole Overview:The Regulatory Affairs Manager will be responsible for overseeing all regulatory aspects of projects, ensuring compliance with global guidelines, and leading regulatory submission. Responsible for preparing, reviewing, and compiling high-quality CMC (Chemistry, Manufacturing, and Controls) documentation for regulatory...
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Regulatory Affairs
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Wagholi, Pune, Maharashtra, India SYS Research Full time**Responsibilities** As a regulatory affairs officer, you'll need to: - ensure that a company's products comply with the regulations of the regions where they want to distribute them - keep up to date with national and international legislation, guidelines and customer practices - collect, collate and evaluate scientific data from a range of sources -...
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Manager Regulatory Affairs
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Pune, Maharashtra, India Emcure Full time ₹ 6,00,000 - ₹ 18,00,000 per yearRole: Regulatory Affairs ManagerJob Location: PuneExp: 8-14 YearsQualification: B.Pharm/M.PharmJob Responsibilities:Dossier preparation, Submission, Compilation, Query Response, Variation fillingResponsible for pre and post approval activities.Handling Europe Market.Strong knowledge of EU regulatory frameworks and guidelines (e.g., EMA, ICH, eCTD).Experience...
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Regulatory Affairs Officer
1 week ago
Wagholi, Pune, Maharashtra, India Statistical Pharma Full time**Regulatory Affairs Officer Duties & Responsibilities** 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,...
