• Participate on product development teams to insure US and EU regulatory requirements are incorporated as part of the development process • Author submissions and other regulatory documents to obtain approval to bring new or modified products to market including but not limited to 510(k)’s, PMA’s, Technical Files, and Design Dossiers • Review and approve labels, labeling and marketing/sales collateral materials for pre and post - market applications • Support marketing, R&D and manufacturing teams in regulatory assessment of proposed changes or product transfers • Address and advise teams on appropriate pathways to market • Interface and coordinate with the FDA, Notified Bodies, Competent Authorities and other regulatory agencies on submissions, approvals or other issues • Establish and maintain regulatory information systems both electronically and hard copy • Interpret existing and/or new regulatory requirements as they relate to company products and procedures. • Review and approve change requests with regard to US and EU regulatory requirements • Communicate any regulatory body correspondence on submissions to the appropriate team(s) and RA management • Develop, implement and maintain regulatory SOP’s • Conduct quality and regulatory training Candidate Profile: 1. Certified ISO 13485 , Medical Device Directive (MDD) and MDR Professional 2. Ability to work independently in fast-paced environment with little supervision. 3. Minimum 3-5 years experience in FDA and EU regulated medical device industry

More about this Associate - Regulatory Affairs job

PANACEA MEDICAL TECHNOLOGIES PVT LTD is aggressively hiring for the job profile of Associate - Regulatory Affairs at Bengaluru in Whitefield locality. Kindly go through the FAQs below to get all answers related to the given job. 1. How much salary can I expect? Ans. You can expect a minimum salary of 20,000 INR and can go up to 50,000 INR. The salary offered will depend on your skills, experience and performance in the interview. 2. What is the eligibility criteria to apply for this job? Ans. The candidate should have completed Graduate degree and people who have 1 to 31 years are eligible to apply for this job. You can apply for more jobs in Bengaluru to get hired quickly. 3. Is there any specific skill required for this job? Ans. The candidate should have Good (Intermediate / Advanced) English skills and sound communication skills for this job. 4. What are the timings of the job and how many working days are there? Ans. It is a Full Time job having timing from 09:00 AM - 6:30 PM and will have 6 working days i.e., Monday to Saturday. 5. Is it a work from home job? Ans. No, it’s not a work from home job and can’t be done online. You can explore and apply for other work from home jobs in Bengaluru at apna. 6. Are there any charges or deposits required while applying for the role or while joining? Ans. No work-related deposit needs to be made during your employment with the company. 7. How can I apply for this job? Ans. Go to the apna app and apply for this job. Click on the apply button and call HR directly to schedule your interview. 8. What is the last date to apply? Ans. The last date to apply for this job is 24-Feb-2022. For more details, download apna app and find Full Time jobs in Bengaluru. Through apna, you can find jobs in 74 cities across India. Join NOW!