Job Summary: We are seeking a highly motivated and detail-oriented Clinical Affairs Specialist with strong experience in post-market surveillance, Post-market Clinical Follow-up (PMCF), Periodic Safety Update Reports (PSUR), clinical evaluation under MDR, and health complaint assessment within the pharmaceutical and medical device industry . The ideal candidate will support regulatory compliance and safety monitoring in alignment with US FDA, EU MDR and relevant global regulatory standards. Key Responsibilities: Prepare and manage Post-Market Surveillance (PMS) activities for pharmaceutical and medical device products. Prepare and update Post-market Clinical Follow-up (PMCF), Periodic safety update report (PSUR) in compliance with EU MDR and other relevant regulations. Conduct and compile Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) as per MDR (EU) 2017/745 requirements. Review, assess, and investigate health complaints, adverse events, and product safety issues. Collaborate with cross-functional teams including Regulatory Affairs, Quality Assurance, and other relevant department. Maintain up-to-date knowledge of global regulatory requirements related to PMS, PMCF, PSUR, and clinical evaluations. Support audits and inspections related to PMS, PMCF, PSUR, and health complaint documentation. Ensure accurate documentation and timely submission of regulatory reports. Other tasks as assigned by management. Qualifications & Requirements: Bachelor's or Masters degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field. Minimum 5-7 years of experience in clinical affairs, regulatory affairs, or related function in the pharmaceutical or medical device industry. In-depth understanding of EU MDR (2017/745), ISO 14155, and applicable regulatory guidelines. Strong experience with PSUR preparation, PMS plans/reports, and clinical evaluation documentation. Familiarity with health complaint management systems and risk assessment methodologies. Excellent written and verbal communication skills. Ability to work independently and manage multiple projects. Preferred Skills: Experience working with Notified Bodies and regulatory agencies. Prior involvement in MDR transition projects. Knowledge of pharmacovigilance and medical device vigilance systems

NeilMed Pharmaceuticals is a leading manufacturer in nasal saline OTC(over the counter) products. We are committed to providing exceptional customer service and satisfaction. We ensure that our products meet the highest level of quality and safety standards. We're constantly looking for experienced, self motivated, hard working, and dependable individuals to join our rapidly growing company. This position is NIGHT SHIFT only. We are looking for a skilled Call center representatives to work from office . We do not provide transportation and food. Roles and Responsibilities Developing objectives for the day-to-day activities Addressing customer queries, resolving issues, and providing information. roles involves outbound sales activities also Should have experience in voice process inbound and outbound calls to doctors, medical professionals and customers related to products and general enquiry. Identify the needs of customers, resolve issues, and provide solutions and maintain good customer relations. Respond to dissatisfied customers, and problem-solving skills Maintain records of the conversations with the customer and analyse the data Input into the company application platform to keep each customer record updated. Build sustainable relationships with the team. Must be excellent in E-mail and writing skills as you will be interacting with international customers. Working hours would be purely night shift with any 5 days in a week working. Use company policies to determine if there can be an immediate resolution to a customer issue or if that issue requires managerial input. Need to know priority measures and handle the issues professionally. must be an organized, reliable and results-driven professional. must have excellent customer service and communication skills. Desired Candidate Profile 1+ years experience in telemarketing / outbound call center environment Excellent verbal and written communication skills are crucial for all roles Experience in customer service, sales, or related fields is often required. Computer literacy and familiarity with call center software or CRM tools . we are looking for candidates who can join us immediately or latest within 15days. Customer focus and adapt to different personality types to work in a team. Be a strong team player with pleasant attitude with responsiveness. Good knowledge of excel is a must. Flexibility in shifts, offs & working hours. ' Bachelors Degree Outstanding communication and interpersonal skills Perks and Benefits We have been operational for more than 16 yrs plus and job security is a key point. Looking for male candidates as it is purely night shift and we do not provide food and transport.