Regulatory Affairs Operations Analyst
3 weeks ago
Summary This position is responsible for the creation identification collection and entry of regulatory affairs information of medical devices Support related regulatory affairs activities such as assessment execution and management of regulatory data and information to support all regulatory needs and objectives of the business Requires the analysis of data problem solving analysis and in depth evaluations of various factors P2-14313Essential Responsibilities Identify submit and maintain regulatory information in Regulatory databases Assess necessity for submitting a 510 k application for proposed device changes Prepare internal Non-Filing Justifications U S for changes that do not require a 510 k submission Prepare technical files for CE marking with appropriate input help from various functions R D Quality Manufacturing etc in a timely manner Assess necessity for notification to the Notified Body about significant changes to CE marked products in a timely manner Prepare documentation updates for non significant changes in a timely manner Review approve labeling to ensure regulatory compliance in a timely manner Complete review approve documentation to ensure regulatory compliance Coordinate and collect specific registration information with R D Manufacturing QA Medical and other applicable departments as necessary to update Regulatory documentation Submit regulatory information on products to external databases when deemed necessary Responsible for writing and updating standard operating procedures SOP work instructions WI and policies on an as-needed basis Coordinate and respond to requests for product data and information Qualifications Educational Background B S degree or higher in a technical discipline preferably in computer science engineering bioengineering biology or chemistry Professional Experience 2-4 years Regulatory Affairs experience in medical device companies including international product registrations new product development and sustaining engineering Knowledge and SkillsKnowledge Working knowledge of 510 k for both medical devices MDD 93 42 EEC and working knowledge of 21 CFR 820 -Quality System Regulation and working knowledge of standards and FDA guidances Working knowledge of all material related regulatory requirements e g Prop 65 CONEG DOT IATA IMO OSHA etc in the US Europe and Canada Skills Proficient in using Microsoft Word Excel and PowerPoint Proficient in English Strong communication Skill both oral and written Strong project management skills Must be able to handle multiple tasks and attention to detail Self-motivated comfortable with working with people remotely Organized analytical thinker with attention to details Required SkillsOptional Skills Primary Work Location IND Bengaluru - Technology CampusAdditional LocationsWork Shift
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Regulatory Affairs Specialist
1 day ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000Regulatory Affairs SpecialistThis role is a great opportunity for individuals with a strong understanding of regulatory affairs and a passion for ensuring compliance. The Regulatory Affairs Specialist will play a critical role in assisting international regulatory teams with navigating evolving business needs in the Indian market.Key...
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Regulatory Affairs Specialist
4 days ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000Job Title: Regulatory Affairs Specialist">Job Description:">We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to manage and support regulatory submissions, ensure compliance with global regulatory requirements, and maintain the highest standards of operational excellence in regulatory processes.">Technical skills: Deep...
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Regulatory Affairs Professional
5 days ago
Bengaluru, Karnataka, India beBeeRegulatory Full timeRegulatory Affairs ProfessionalThis role is responsible for leading the development and execution of regulatory strategies and documents in support of clinical trials and product registration.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with relevant regulations and guidelines.Prepare and review regulatory documents,...
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Bengaluru, Karnataka, India Immuneel Therapeutics Pvt. Ltd. Full timeAbout ImmuneelImmuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India and the world. For more details, please refer Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, collaborating globally and Creating (3 Cs) solutions. Our flexible,...
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Bengaluru, Karnataka, India Immuneel Therapeutics Pvt. Ltd. Full timeAbout Immuneel Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India and the world. For more details, please refer We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, collaborating globally and Creating (3 Cs) solutions. Our...
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Regulatory Affairs Professional
5 days ago
Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 8,46,992 - ₹ 12,99,898Regulatory Affairs AssociateThis is a critical role that involves providing regulatory support to various departments across the organization. The successful candidate will be responsible for ensuring that all regulatory activities align with business needs.Key Responsibilities:The Regulatory Affairs Associate will be responsible for:Providing regulatory...
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Regulatory Affair Manager
3 weeks ago
Bengaluru, Karnataka, India Natural Biogenex Pvt Ltd Full timeNote: The selected candidate must be willing to visit the manufacturing facility in Vasanthanarsapura, Tumkur at least two days a week and/or as required based on operational and regulatory needs.Job Title: Regulatory Affairs ManagerLocation: Jayanagar 2nd block, Bengaluru/Vasanthnarasapura KIADB Industrial Area, Tumkur, KarnatakaExperience: 12 - 15 years...
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Regulatory Affair Manager
4 weeks ago
Bengaluru, Karnataka, India Natural Biogenex Pvt Ltd Full timeJob DescriptionNote: The selected candidate must be willing to visit the manufacturing facility in Vasanthanarsapura, Tumkur at least two days a week and/or as required based on operational and regulatory needs.Job Title: Regulatory Affairs ManagerLocation: Jayanagar 2nd block, Bengaluru/Vasanthnarasapura KIADB Industrial Area, Tumkur, KarnatakaExperience:...
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Regulatory Affairs Specialist
2 days ago
Bengaluru, Karnataka, India Biocon Biologics Full timePosition SummaryThe Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...
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Regulatory Affair Manager
3 weeks ago
Bengaluru, Karnataka, India Natural Biogenex Pvt Ltd Full timeNote: The selected candidate must be willing to visit the manufacturing facility in Vasanthanarsapura, Tumkur at least two days a week and/or as required based on operational and regulatory needs.Job Title: Regulatory Affairs ManagerLocation: Jayanagar 2nd block, Bengaluru/Vasanthnarasapura KIADB Industrial Area, Tumkur, KarnatakaExperience: 12 - 15 years...
