Medical Device Compliance Specialist

2 days ago

Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 9,00,000 - ₹ 12,00,000
Job Description

As a regulatory compliance executive, you will play a crucial role in ensuring that our products meet the highest standards of safety and efficacy. You will be responsible for reviewing product labelling and advertising materials to ensure they comply with regulatory requirements.

You will also contribute to the complaint handling process and prepare submissions to health authorities. Additionally, you will provide regulatory support to manufacturing and R&D teams by performing significant change impact assessments and developing and maintaining a regulatory information management system.

Furthermore, you will co-author regulatory plans for new product introductions and product line extensions, author regulatory department procedures and templates, and provide guidance, training, and direction on regulatory topics to teammates.

Required Skills and Qualifications
  • In-depth knowledge of medical device regulations and standards, including FDA QSR, MDSAP, ISO 13485, (EU) MDR 2017/745, and ISO;
  • Experience in ophthalmology or surgical instrument field preferred;
  • Experience in medical device development, quality assurance, or regulatory affairs is highly desirable;
  • Familiarity with documentation and submission requirements for regulatory bodies is an advantage;
  • BS/BA in Engineering, Life Sciences, or an equivalent technical field;
  • MS in Regulatory Affairs or RA/QA certifications a plus;
Benefits

We offer a safe and respectful workplace where everyone can be themselves, feel free to bring their whole selves to work, and use their unique talents, knowledge, expertise, experiences, and backgrounds to create meaningful outcomes.

Additionally, we promote and support non-linear career growth for the right talent and offer opportunities for professional development and advancement.

Others

Plan, coordinate, and prepare document packages for regulatory submissions and renewals with emphasis on EU Technical Files, MDSAP, and other regulated countries.

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