Medical Affairs Jobs

Job Title:Medical Device Regulatory Affairs SpecialistBhopal LocationCompany: Intense Medical & Dental System Pvt Ltd Bhopal.Job Brief:We are looking for a skilled Regulatory Affairs Specialist to manage and coordinate regulatory compliance for our medical devices. This role requires strong communication with channel partners, collaboration with documentation teams, and ensuring all products meet regulatory standards for both domestic and international markets.______________Key Responsibilities:* Ensure medical devices comply with all applicable national and international regulatory requirements and standards* Prepare and submit regulatory submissions, including 510(k), PMA, and other global market registrations* Communicate with regulatory authorities (such as the FDA, CDSCO) to handle queries and support approval processes* Monitor and interpret changes in medical device regulations and assess their impact on the company* Provide regulatory guidance and training to cross-functional teams including R&D, QA/RA, and Product Development* Develop and implement regulatory strategies to support new product development and market expansion* Maintain organized, up-to-date documentation to demonstrate compliance and support audits* Collaborate with channel partners and internal documentation specialists to ensure consistent regulatory alignment______________Requirements:* Bachelors degree in Biomedical Engineering, or B.E electronic commination. or a related discipline* 34 years of experience in medical device regulatory affairs* Strong knowledge of domestic and international medical device regulations (FDA, EU MDR, ISO 13485, CDSCO, etc.)* Excellent verbal and written communication skills* High attention to detail, analytical thinking, and problem-solving ability* Experience working collaboratively across multiple teams______________Preferred Qualifications:* Regulatory Affairs Certification (RAC)* Experience with Class II or III medical devices* Familiarity with quality systems (e.g., ISO 13485, FDA QSR)Key Responsibilities: Quality Assurance and Control Regulatory Compliance Process Improvement Supplier Quality Management Key Documentation and Reporting

Job Title: Assistant Manager Scientific / Deputy Manager Scientific (Medical affairs)Location: MumbaiJob Type: Full-timeExperience: 1-3 yearsCompany Overview:We are a leading pharmaceutical organization committed to advancing healthcare through innovative solutions. Our dynamic team fosters growth and development while ensuring the scientific integrity of our products and services. We are currently looking to hire an Assistant Manager Scientific or Deputy Manager Scientific to join our Medico Marketing team in Mumbai.Job Overview:As an Assistant Manager Scientific or Deputy Manager Scientific, you will play a pivotal role in supporting the marketing and sales teams with scientific expertise. You will collaborate across functions to ensure the accuracy and scientific integrity of marketing materials, product launches, and ongoing brand management. This role requires a deep understanding of scientific data and the ability to communicate it effectively to non-scientific stakeholders.Key Responsibilities:Product Launch:Conduct comprehensive literature reviews to support the creation of medical manuals, presentations, and marketing materials.Lead the development of product launch presentations, delivering insights on therapy areas and product specifics to the marketing and sales teams.Responding to Queries:Serve as the scientific point of contact for the field force and healthcare professionals, providing accurate, evidence-based responses to support relationships with customers.Scientific Support to the Brands:Stay up-to-date with scientific data, clinical trials, and guidelines relevant to the companys products and therapy areas.Provide technical support to marketing and sales teams, ensuring scientific accuracy in all materials.Training:Develop and deliver training programs (fresher and refresher) for medical representatives, ensuring they are well-versed in the latest product and therapeutic information.New Product Ideation:Provide me

1. Completing all planned customer visits on time and to the levels outlined in application manual.2. Work closely with the sales team to develop and optimize product attributes to achieve maximum customer preference in targeted segments, providing technical support.3. Perform post-sale demos to the customers to develop product understanding and applications knowledge.4. Occasional training of clinical staff on designated equipment. Help customers to understand all the functions of the products and make the best use it.5. Help customers and distributors to solve UIS product issues, response in time.6. Collect distributors and end-users feedbacks; summarize and analyze customer requirements for future product development and upgrade.7. Train the distributors team for better product demo to end users.8. Provide suggestions for the development of distributors application team.9. Keep good relationship with local opinion leaders.10. Support doctors in Clinical Research11. Product Research and new product evaluation12. Have a deep understanding of the key accounts which include good development and maintenance of customer relationship.13. Performing clinical applications 14. Supporting marketing activities15. Conduct product evaluation and share feedback/suggestions with Product Team

Job Description: Should be responsible for preparation of qualitative medical writing deliverables in any therapeutic area Should have good experience in scientific and regulatory writing (Protocol writing, CSR, Manuscript, Abstract, Review articles and Medico-marketing inputs) Should be able to develop LBL, Poster, News-letters, KOL cases, booklets, atlas, guideline booklet, product monographs, calendars, compendium, customized journals, handbooks, conference abstract booklets, yearbooks, KOL opinion booklets, case studies, CMES, etc. Should have hands on experience in literature search and systematic review Should be accountable for medical writing deliverable and should ensure work on assigned projects adheres to industry/international standards Should be able to draft article on Health Economic Outcome Research and understanding on subject will be added advantage Should be responsible for continual improvement of in-house medical writing capabilities Should have an excellent understanding of all aspect of ICH-GCP; keen insight on external clinical publication practices and standards. Should liaise with internal team, clients, authors and KOLsExperience: Min 4 - 7 years experienceQualification: Bachelors degree / Masters Degree in any Pharma / Lifesciences/ Science related field. Excellent verbal and written skills (English). Good organizational, interpersonal, and team skills. Ability to deliver results under pressure. Goal oriented, self-motivated; able to work independently but within a team environmentDesired Skills/Experience: A good understanding of the healthcare market, challenges, growth prospects and healthcare delivery operations Strong customer and contact network in healthcare domain A minimum of three five years medical writing experience within the pharmaceutical industry or a contract research organisation. Able to work independently, initiate their own projects as needed to streamline their wo

We have vacant of 5 Product Specialist Jobs in Yamunanagar, Haryana, Experience Required : 2 Years Educational Qualification : Other Bachelor Degree Skill Regulatory Affairs, Marketing, Institutional Sales, Medical Equipment, Communication Skills, Process Audit etc.,