
Regulatory Affairs Executive
1 week ago
We are hiring Regulatory Affairs Executive for a Medical Device Equipment company.
Key skills: Thorough Knowledge of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017
- 2+ years of experience implementing test strategies, test plans and test cases for validation and verification in FDA-compliant medical device industry
- Demonstrated success in a start-up, entrepreneurial work environment
- Thorough knowledge of FDA Quality System requirements, ISO 13485:2012 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
- 2+ years of experience in verification/validation of products incorporating scalable data acquisition, processing, management, and reporting functionalities.
- 2 or more years of experience with QMS implementation that complies with, MDD /93/42/EEC, ISO 13485 and ISO 14971 standards.
- Lead role (administrative or technical) in one or more FDA submissions for approval of a medical device
- Project management skills and proficiency and analyzing and interpreting test data
Regards
Pay: ₹10,572.25 - ₹25,000.00 per month
Schedule:
- Day shift
**Experience**:
- total work: 1 year (preferred)
Work Location: In person
-
▷ Immediate Start! Manager
4 days ago
Gurgaon, Haryana, India Sun Pharmaceutical Industries Full timeJOB DESCRIPTION Position Manager Senior Manager Job Location Gurgaon Education M Pharm Department Global Regulatory Affairs Job Responsibilities Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets like EU Canada...
-
Gurgaon, Haryana, India Johnson & Johnson Full timeAt Johnson Johnson we believe health is everything Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across...
-
Gurgaon, Haryana, India Sun Pharmaceutical Industries Full timeReporting to Sr Vice President - Regulatory Affairs Qualification Master s Degree in Pharmacy PhD in Pharmacology or Pharmaceutics desirable Experience 10 years Location Baroda Mumbai Responsibilities Work with various cross-functional teams within the organization to ensure that availability of a development execution and submission...
-
[Urgent] Manager, Public Policy
3 weeks ago
Gurgaon, Haryana, India Wipro Full timeWe use cookies to offer you the best possible website experience Your cookie preferences will be stored in your browser s local storage This includes cookies necessary for the website s operation Additionally you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve website s performance as well as...
-
Quality Assurance
5 days ago
Gurugram, Haryana, India Ethics Group Of Companies Full timeQuality Systems Management: Develop, implement, and maintain quality systems and processes to ensure compliance with regulatory requirements, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP). - Document Control: Manage document control processes, including document creation, review,...
-
Assistant Manager- Regulatory Affairs
4 weeks ago
Gurgaon, Haryana, India BD Full timeSummary Dossier lifecycle management import license filing preparation and submission Maintenance of database Labeling review as per MDR 2017 and Legal metrology RIM cross functional colloboration We are the makers of possibleBD is one of the largest global medical technology companies in the world Advancing the world of healthxe2x84xa2 is our Purpose ...
-
Government Affairs Manager
2 weeks ago
Gurgaon Rural, Haryana, India The Mullings Group Full time ₹ 12,00,000 - ₹ 36,00,000 per yearOur client is in search of a Government Affairs Manager for a MedTech company onsite in Gurgaon, India.The RoleThe Government Affairs Manager will be responsible for public policy engagement, government KOL advocacy, and initiating project-based collaborations with central and state health authorities to influence healthcare policy development. The role will...
-
Gurugram, Haryana, India PinnacleU Full timePosition: GM/AVP - Public Affairs & Government Partnerships Location: Gurgaon Working Days: Monday to Saturday (5.5 days) Experience Required: 7+ years Client: Staffing solutions for blue collar hiring **Role Overview**: We are seeking GM/AVP - Public Affairs & Government Partnerships to lead the execution of government engagement, policy initiatives,...
-
Executive- Drug Regulatory Affairs
7 days ago
Haryana, India Evolet Healthcare Pvt. Ltd Full time**Roles and Responsibilities** - Having experience in dossier compilation (CTD & ACTD) for CIS, ASEAN, LATAM and AFRICAN countries. - Controlling the whole process of registration product from beginning till the end. - Evaluation of Bioequivalence and Clinical Trials (preferably). - **Must be B.Pharm/M.Pharm**: - Having knowledge of ICH guideline. - Having...
-
Medical Affairs Professional
7 days ago
Gurugram, Haryana, India Lilly Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...