Senior Technical Specialist - MDR, ISO 13485, MDD
India
Apply now
Job Description
Senior Technical Specialist - MDR, ISO 13485, MDD

Job Summary

The Senior Technical Specialist is responsible for leading technical activities related to mdr, ISO 13485, and MDD compliance. This role involves ensuring adherence to regulatory standards and implementing quality management systems within the organization.

Key Responsibilities

1. Develop and implement strategies to ensure compliance with mdr, iso 13485, and mdd regulations.
2. Lead the planning and execution of internal audits to assess compliance levels.
3. Collaborate with cross functional teams to address and resolve compliance issues.
4. Stay updated on changes in regulatory requirements and communicate necessary adjustments to stakeholders.
5. Provide guidance and training to team members on mdr, iso 13485, and mdd standards and practices.

Skill Requirements

1. Proficiency in medical device regulation (mdr), iso 13485, and medical device directive (mdd).
2. Strong analytical and problem-solving skills related to compliance and quality management.
3. Excellent communication and interpersonal abilities to work effectively with internal teams and external stakeholders.
4. Attention to detail and a high level of accuracy in regulatory documentation.
5. Project management skills to lead compliance initiatives and audits effectively.

Other Requirements

1.Relevant certifications in MDR, ISO 13485, or MDD are a plus.
Apply now
Information at a Glance

Why HCLTech?

At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first.

HCLTech is a global technology company, home to more than 220,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending December 2024 totaled $13.8 billion.
23 Benefits At HCLTech, we believe in empowering our employees with comprehensive benefits that support their professional growth and enhance their well-being. When you sign up for a career with us, you gain access to: https://rmkcdn.successfactors.com/147eb21f/a701dca9-f32d-4fc9-9447-6.svg Industry-benchmarked compensation https://rmkcdn.successfactors.com/147eb21f/b0c54381-ddcc-4a33-9b35-9.svg Best-in-class healthcare benefits https://rmkcdn.successfactors.com/147eb21f/b73027be-7aae-4d36-a090-4.svg Personal time off https://rmkcdn.successfactors.com/147eb21f/d5b4fdfd-2e99-4e26-9878-9.svg Maternity and paternity benefits https://rmkcdn.successfactors.com/147eb21f/3d42b0fc-4652-435a-9ece-c.svg Access to skills / higher education programs/resources https://rmkcdn.successfactors.com/147eb21f/aeddeaf2-9e25-4584-ad11-d.svg Discounts on products and services via Benefit Box https://rmkcdn.successfactors.com/147eb21f/a9609a3b-2700-4b3c-9d90-a.svg Participate in CSR programs and live life with a purpose https://rmkcdn.successfactors.com/147eb21f/c6e33851-710f-4634-bd69-f.svg Opportunities to grow and advance your career Note: The benefits listed above vary depending on the nature of your employment and the country where you work. Some benefits may be available in some countries but not in all.