Regulatory affairs analyst
3 hours 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 DescriptionKeeps 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 WorldCompiles 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 marketsMaintains 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 ExperiencesBachelor’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 offerA unique opportunity to become part of growing organization in India being part of a global market leader in Xray imaging components.Excellent development potentialAn international work environment with global teams collaborating on various projects across several countries.Competitive compensation package including participation in Varex incentive plansCorporate Health BenefitsAdditional 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
1 hour 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
9 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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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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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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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,...
