Are you passionate about regulatory compliance and quality management in the healthcare industry? BeatO, a leading health-tech company, is hiring a Regulatory Affairs Specialist in New Delhi, India. This full-time, on-site role offers a chance to work with cutting-edge medical device standards and contribute to a growing organization. If you have expertise in ISO 13485, ISO 9001, or ISO 27001 and a background in pharmacy or life sciences, this could be your next career move!
Job Overview: Regulatory Affairs Specialist at BeatO
BeatO is seeking a detail-oriented Regulatory Affairs Specialist to ensure compliance with international standards like ISO 13485:2016 (Medical Devices), ISO 9001:2015 (Quality Management), and ISO 27001:2022 (Information Security). This role is perfect for professionals with 1-2 years of experience in regulatory affairs or quality assurance within the medical device, pharmaceutical, or healthcare sectors.
Key Responsibilities
- Ensure adherence to ISO 13485, ISO 9001, and ISO 27001 standards.
- Prepare and maintain regulatory documentation, policies, and procedures.
- Coordinate internal and external audits with certification bodies and regulatory authorities.
- Support the development of Quality Management Systems (QMS) and Information Security Management Systems (ISMS).
- Monitor regulatory updates and implement timely changes to company protocols.
- Conduct training sessions to promote compliance awareness.
- Collaborate with cross-functional teams to ensure product and process compliance.
Why Work at BeatO?
BeatO is revolutionizing healthcare with innovative solutions, and this role offers a chance to be part of that mission. Led by professionals like Kartik Arya (Building BeatO | IIMK | Ex-Airtel | Ex-Delhivery), the company values expertise and collaboration. With a growing presence in India, BeatO is an exciting place for career growth in the health-tech space.
Skills and Qualifications You’ll Need
To succeed as a Regulatory Affairs Specialist at BeatO, you’ll need the following:
- Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biomedical Engineering, or a related field.
- Experience: 1-2 years in Regulatory Affairs, Quality Assurance, or Compliance in the healthcare or medical device industry.
- Technical Skills: Strong knowledge of ISO 13485, ISO 9001, and ISO 27001.
- Audit Experience: Familiarity with managing audits and regulatory documentation.
- Soft Skills: Analytical thinking, problem-solving, and excellent communication.
- Teamwork: Ability to collaborate across departments.
