Regulatory Affairs Manager

Miraclus Orthotech Private Limited; Gujarat; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Miraclus Orthotech Private Limited is urgently seeking a Regulatory Affairs Manager for the Kheda, Gujarat location. The candidate should have experience in Medical Device/Pharma or related industries.

The role involves leading regulatory submissions, maintaining CTDs and QMS, and coordinating with global authorities to ensure compliance with EU-MDR, US FDA, and other standards. Strong communication and leadership skills are required.

Qualifications

• Bachelor’s degree in a relevant field. First preference for NIPER graduates.
• Minimum 8 years of medical device experience with people management.
• Knowledge of EU-MDR, US FDA, MDCG, ISO 13485, ISO 14971, ISO 15223-1 and other regulatory standards.
• Must have experience in technical dossier preparation.
• Knowledge of IEC standards such as IEC 60601-1, IEC 62304 is beneficial.

Responsibilities

• Manage regulatory affairs for medical devices, ensuring compliance with EU-MDR, US FDA, ANVISA, MHRA, ISO 13485 standards.
• Develop and maintain regulatory documentation including CTDs, RA submissions, QMS systems.
• Conduct BMR reviews and quality audits to ensure adherence to process validation requirements.
• Collaborate with cross-functional teams to implement change controls and process improvements.
• Ensure timely submission of regulatory applications and maintain accurate records.
• Prepare and update technical documentation as per EU MDR, 510(k), and Indian MDR requirements.
• Prepare and update risk management and usability evaluation per ISO 14971 and IEC 62366-1.

Skills

Communication skills

Interpersonal skills

Time management

Leadership

Cross-functional teamwork

MS Office

Education

Bachelor’s degree in relevant field

NIPER graduates preferred

Tools

MS Office

Job description

Urgent Requirement of Regulatory Affairs Manager for Kheda, Gujarat location.

Candidate having experience of Medical Device/Pharma or any other related industry will be given first preference.

Regulatory Affairs Manager

Role & Responsibilities

What you will be doing :

• Manage regulatory affairs for medical devices, ensuring compliance with EU-MDR, US FDA, ANVISA, MHRA, ISO 13485 standards.
• Develop and maintain regulatory documentation including CTDs, RA submissions, QMS systems.
• Conduct BMR reviews and quality audits to ensure adherence to process validation requirements.
• Collaborate with cross-functional teams to implement change controls and process improvements.
• Ensure timely submission of regulatory applications and maintain accurate records.
• Effectively registering in various countries. Looking after the audit criteria and requirements of various countries.
• Prepare and update technical documentations as per EU MDR and 510 (k), Indian MDR 2017 regulatory requirements as required.
• Prepare and update risk management and usability evaluation as compliance with ISO 14971 and IEC 62366-1
• Prepare and/or review labeling, IFU, surgical techniques, Clinical Testing and promotional materials for compliance with regulatory requirements.
• Prepare and update divisional SOPs and recommend timely changes to ensure regulatory compliance.
• Planning, Compilation, review and submission of Documents as per Country Specific regulatory guideline in medical device and coordinating with them for registration.
• Leads and compiles all documents required in submissions, license renewal and annual registrations in line with business plans.
• Apply knowledge and understanding of the regulatory frameworks, processes, and procedures to maintain compliance.
• Monitors and improves regulatory tasks tracking systems effectively.
• Identify and assess changes in applicable regulations, standards and guidance and perform changes accordingly and maintain the product compliance.
• Effectively interact with internal stakeholders and external stakeholders (Notified Bodies, distributor, suppliers and other regulatory authorities) on defined matters.
• Face external audits / inspection, coordinate and communicate with external auditors / inspectors for compliance.

Essential Requirements

• Bachelor's degree from relevant universities. First preference will be given to NIPER pass outs.
• Minimum 8-year experience in Medical device with proven people management skills.
• Should have knowledge and understanding of the regulatory frameworks, processes, and procedures to maintain compliance.
• Should have knowledge of EU-MDR, USFDA, MDCG, ISO 13485, ISO 14971, ISO 15223-1 and other regulatory standards.
• Must have experience in technical dossier preparation.
• Knowledge of IEC standards such as IEC 60601-1, IEC 62304, etc will be beneficial.
• Knowledge of Orthopaedic implants, Orthopaedic instruments and Surgical Robotics Instruments will be preferred.
• Good command of MS Office programs.
• Excellent communication, interpersonal and time management skills and ability to work in and lead cross functional teams,
• Well organized, aptitude for paperwork, good follow-up skills, strong organizational and co-ordination skills,

Desirable Requirements

• Demonstrated ability to analyse data and resolve critical issues. Demonstrated ability to lead highly efficient teams.
• Background or prior experience in MedTech/Orthopaedic domain is a plus.
• Active and good listener, team player, effective problem solving skills, result and quality orientation,
• Good command of both written and spoken English.

Why Work For US

• Miraclus Orthotech Pvt Ltd is an innovative and dynamic company at the forefront of Orthopaedic technology, providing employees with a unique opportunity to contribute to the advancement of medical science.
• Joining Miraclus Orthotech means becoming part of a team dedicated to improving the lives of patients by developing cutting-edge Orthopaedic solutions that enhance mobility, reduce pain, and restore quality of life.
• We foster a collaborative work environment that encourages creativity, critical thinking, and teamwork, empowering employees to make meaningful contributions and drive positive change.
• At Miraclus Orthotech, we invest in the professional growth and development of our employees, providing ample opportunities for skill enhancement, training, and career advancement.
• As a leader in the Orthopaedic industry, we offer a diverse range of projects and challenges, ensuring that every day brings new opportunities to learn, innovate, and excel.
• We prioritize work-life balance and employee well-being, offering flexible work arrangements, comprehensive benefits packages, and a supportive culture that values mental and physical health.
• Miraclus Orthotech values diversity and inclusivity, fostering an environment that celebrates different perspectives, experiences, and backgrounds, making it an enriching and fulfilling place to work.
• We are committed to maintaining the highest standards of ethics, integrity, and patient safety, providing our employees with a strong sense of purpose and pride in the work they do.
• Joining Miraclus Orthotech means being part of a global network of professionals, collaborating with experts and thought leaders in the field of Orthopaedics to drive innovation and make a lasting impact.
• Our company culture promotes open communication, transparency, and a shared passion for making a difference, creating a supportive and engaging work environment that inspires employees to thrive.

What You'll Achieve

• By joining Miraclus Orthotech, you will have the opportunity to make a tangible impact on the lives of patients worldwide, contributing to the development of innovative Orthopaedic solutions that improve mobility and enhance quality of life.
• As a member of our team, you will play a vital role in advancing Orthopaedic technology, working alongside industry experts and thought leaders to drive innovation and shape the future of Orthopaedic care.
• At Miraclus Orthotech, you will have the chance to expand your knowledge and expertise in the field of Orthopaedics, with access to cutting-edge technologies, training programs, and continuous learning opportunities.
• You will work in a collaborative and dynamic environment, where your ideas and contributions will be valued and encouraged, allowing you to unlock your full potential and achieve professional growth.
• As part of our team, you will be involved in multidisciplinary projects and collaborations, collaborating with talented professionals from diverse backgrounds, and fostering a culture of innovation and collaboration.
• Working at Miraclus Orthotech, you will have the chance to develop and refine your skills through challenging and meaningful projects, contributing to the development of groundbreaking Orthopaedic solutions that push the boundaries of medical science.
• You will have the opportunity to work with state-of-the-art facilities and advanced tools, enabling you to carry out your work with precision and efficiency, ensuring the highest quality standards in our products and services.
• At Miraclus Orthotech, we encourage and support professional growth and career advancement, providing mentorship, leadership opportunities, and a clear path for personal and professional development within the organization.
• As a valued member of our team, you will have the satisfaction of working in a mission-driven company that prioritizes patient well-being, ethical practices, and the highest standards of quality in all aspects of our work.
• By working at Miraclus Orthotech, you will be part of a global network of professionals, collaborating with experts from around the world and expanding your professional network, opening doors to future opportunities and career growth.

Who We Are

• Miraclus Orthotech Pvt Ltd is a leading Orthopaedic technology company dedicated to transforming the field of Orthopaedics through innovative solutions and advanced medical devices.
• We are a team of passionate professionals, including engineers, researchers, and medical experts, united by a common goal of improving patient outcomes and revolutionizing Orthopaedic care.
• With a strong focus on research and development, we leverage cutting-edge technologies and scientific advancements to create state-of-the-art Orthopaedic implants and surgical instruments.
• Miraclus Orthotech takes pride in its commitment to excellence, upholding the highest quality standards in our products, and prioritizing patient safety and satisfaction.
• As an organization, we strive to make a positive impact in the global healthcare community by delivering reliable, innovative, and patient-centric Orthopaedic solutions that address the unique needs of individuals around the world.