Regulatory Affairs Specialist – Medical Devices (Pune, India)
Summary: Are you a seasoned Regulatory Affairs Specialist with a passion for the medical device industry? We are seeking a driven and knowledgeable individual to join our team in Pune, India. As a Regulatory Affairs Specialist, you will play a vital role in ensuring compliance with US FDA and EU MDR regulations, as well as contributing to global regulatory submissions. This is an excellent opportunity to advance your career, collaborate with cross-functional teams, and contribute to the development and commercialization of innovative medical devices.
About Us:
[Insert a brief, compelling paragraph about your company – Cyient – focusing on its mission, values, and role in the medical device industry. This will help attract candidates who align with your company culture.]
Job Description:
We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our growing team in Pune, India. The successful candidate will be responsible for developing and executing regulatory strategies, preparing submissions, and ensuring compliance with applicable regulations for medical devices. This role requires a deep understanding of US FDA and EU MDR regulations, as well as experience with global regulatory submissions.
Key Responsibilities:
- Regulatory Strategy & Planning: Develop and implement comprehensive regulatory strategies for Class I, II, and III medical devices targeting the US and EU markets.
- Submission Preparation: Prepare, review, and submit regulatory submissions, including 510(k)s, PMAs, Technical Documentation (TD), and Design Dossiers (DD).
- Cross-Functional Collaboration: Collaborate closely with R&D, Quality, Clinical, and Manufacturing teams throughout the entire product lifecycle, from concept to post-market surveillance.
- Change Control Assessment: Evaluate the regulatory impact of product and process changes, ensuring compliance and preparing all necessary documentation.
- Audit Support: Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and providing necessary documentation and support.
- Labeling and Promotion Review: Review and approve product labeling, Instructions for Use (IFU), and promotional materials to ensure compliance with relevant regulations.
- UDI and EUDAMED Compliance: Ensure compliance with Unique Device Identification (UDI) requirements and support submissions to the European Database on Medical Devices (EUDAMED).
- Post-Market Surveillance: Provide oversight for post-market surveillance activities, including vigilance reporting, adverse event handling, and trend analysis.
- Regulatory Authority Communication: Serve as a point of contact for communication with regulatory authorities, including the FDA, Notified Bodies, and other relevant agencies.
- Mentorship and Training: Mentor junior team members and provide training on evolving regulatory requirements and best practices.
Required Qualifications:
- Experience: A minimum of 8 years of experience in Regulatory Affairs within the medical device industry is required.
- Regulatory Knowledge: Possess a strong understanding of US FDA regulations (21 CFR Part 820) and EU MDR (2017/745).
- Submission Experience: Hands-on experience in preparing and submitting 510(k), PMA, Technical Documentation (TD), and Design Dossier (DD) submissions.
- Global Regulatory Exposure: Experience with global regulatory requirements beyond the US and EU is a significant advantage.
- Communication and Documentation: Excellent documentation and communication skills are essential.
- Audit Readiness: Proven ability to prepare for and support regulatory audits.
Location:
Pune, Maharashtra, India
Benefits and Perks:
- Global Exposure: Gain invaluable experience working with global medical device regulatory frameworks.
- Cross-Functional Collaboration: Collaborate with diverse teams across R&D, Quality Assurance, and Clinical departments.
- Competitive Compensation: Receive a competitive salary commensurate with your experience and industry standards.
- Career Growth: Benefit from ample opportunities for career advancement and leadership development.
- [Add any specific benefits your company offers, such as health insurance, paid time off, professional development opportunities, etc.]
Why Join Us?
[Expand on the bullet points in the original content to provide a more compelling reason for candidates to join your company. Focus on the company culture, growth opportunities, and the impact the role will have.]
At [Company Name], we are committed to fostering a collaborative and innovative work environment. We believe in empowering our employees to reach their full potential and make a meaningful contribution to the medical device industry. As a Regulatory Affairs Specialist, you will have the opportunity to work on cutting-edge projects, collaborate with talented professionals, and play a vital role in bringing life-changing medical devices to market. We offer a supportive and inclusive culture that encourages professional development and rewards high performance. Join us and become a part of a team that is dedicated to improving lives through innovation and compliance.
How to Apply:
[Provide clear and concise instructions on how to apply for the position. This may include submitting a resume and cover letter through your company’s careers website.]