Regulatory Specialist and Senior Specialist
4 hours ago
Gentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life. Our success is a result of the talents, dedication and commitment of our people to drive our business forward. We provide career advancement opportunities through Gentell University, leadership development programs and executive mentoring. The Regulatory Affairs Specialist will be assisting international medical device registrations, regulatory submissions and compliance activities across multiple regions. The ideal candidate will have hands-on experience with global regulatory bodies such as ANVISA, MHRA, EU MDR, Health Canada, and FDA. The specialist will ensure products meet global regulatory compliance requirements, review technical documentation, and stay updated with evolving regulatory requirements. Prepare and compile regulatory dossiers to various health authorities (e.g., Prepare, compile, and submit FDA 510(k) premarket notifications for Class II medical devices. · Ensure that regulatory submissions meet the requirements of regional health authorities, including ISO, MDSAP, and other relevant standards. · Maintain familiarity with international regulatory requirements and guidelines to ensure product compliance. · Assist with Ad hoc requests for various regulatory documents in support of registration activities/tenders. · Liaise with cross-functional teams including R&D, Quality Assurance, and marketing to ensure regulatory compliance. · Review and approve product labeling and artwork to ensure compliance with regional regulatory standards. · Conduct gap assessments between current company standards and updated regulatory requirements. · Assist with change control processes, ensuring regulatory compliance when implementing changes to products or processes. · Collaborate with international manufacturing and quality assurance teams to evaluate the impact of changes on regulatory submissions. · Assist with documentation management, ensuring all regulatory records are maintained and readily available for audits or inspections. Bachelor’s degree in life sciences, regulatory affairs, or a related field. ~3-5 years of experience in a similar role. ~ Proven experience with MDR technical documentation authorization. ~ Proven experience preparing and submitting 510(k) applications. ~ Ability to work independently and manage multiple projects simultaneously. ~ Experience with Class I,II and III medical devices classifications. · Prior experience in 510K submissions. · Experience in conducting regulatory gap assessments. · Proficiency in regulatory software and systems for document control and submissions. · Certification in Regulatory Affairs (RAC) is a plus.
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Regulatory Specialist II
2 days ago
Sholinganallur, Chennai, , India Atlas Family Full time ₹ 12,00,000 - ₹ 24,00,000 per yearPosition OverviewThe Regulatory Specialist II supports the planning, preparation, and maintenance of essential regulatory documentation required for clinical research studies. This role ensures compliance with federal, state, and local regulations, as well as KUR's internal policies and procedures. The Regulatory Specialist II collaborates closely with...
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India Givaudan Full time ₹ 12,00,000 - ₹ 24,00,000 per yearJoin us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with passion and creativity, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There's much to learn and many to learn from, with more than 16,000 employees around the world to explore...
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Hyderabad, India Dyaz Innovate Full timeJob Description Company Description Dyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment. Role Description This is a full-time on-site role for a...
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Regulatory Affairs Specialist
2 weeks ago
India Concept Medical Full timeAbout Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in...
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Senior Compliance
4 hours ago
India Hemant Surgical Industries Limited Full timeJob Title: Senior Compliance & Regulatory Affairs Specialist (Medical Devices) Location: Mumbai Department: Regulatory Affairs / Quality Assurance Experience Required: 7–12+ years Industry: Medical Devices / Healthcare / Pharma ______________ Job Summary: The Senior Compliance & Regulatory Affairs Specialist will lead and manage all activities related to...
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▷ [Urgent] Regulatory Affairs Specialist
1 week ago
Gurugram, India Respironics Inc Full timeJob Description Job Title Regulatory Affairs Specialist Job Description Job title: Regulatory Affairs Specialist Your role: Regulatory Affairs Specialist - ISC will have an exciting opportunity to work with the ISC Commercial Regulatory Affairs Team and help business with product registration in the India Sub Continent, actively providing value-added...
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Regulatory Specialist
3 days ago
Alpha India ESI Full time ₹ 12,00,000 - ₹ 36,00,000 per yearChallenge Yourself and Impact the Future Element Solutions Inc (NYSE: ESI) is a leading specialty chemicals company whose operating businesses formulate a broad range of solutions that enhance the performance of products people use every day. Developed in multi-step technological processes, our innovative solutions enable our customer's manufacturing...
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Senior Construction Safety Specialist
4 days ago
India Generic Engineering Constructions and Project LTD Full time ₹ 18,00,000 - ₹ 25,00,000 per yearJob Description – Senior Construction Safety SpecialistPosition: Senior Construction Safety SpecialistLocation: KeralaSalary: INR 18,00,000 per annumRole OverviewWe are seeking a highly skilled and experienced Senior Construction Safety Specialist to oversee and enforce health, safety, and environment (HSE) standards across major road and bridge...
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Regulatory Affairs Operations Specialist
2 weeks ago
Pune, India Respironics Inc Full timeJob Description Job Title Regulatory Affairs Operations Specialist Job Description Job Responsibilities: - International Registrations - Upload, Verify, and Validate the data with new Regulatory Information to the RIM database - Maintain Registration &Licensing Information - Create Submission Packages for International Registrations - Initiate Renewals with...
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Medical Specialist
2 days ago
India Second Medical Opinion (SMO) Full timeWe Are Hiring Senior Medical Specialists Across India Second Medical Online Opinion (SMO) – Transforming Patient Care Nationwide Second Medical Online Opinion (SMO) is building India’s most trusted network of senior medical specialists to offer ethical, unbiased, evidence-based second opinions to patients across the country. We are expanding rapidly and...
