Life Sciences Job Opportunity! Regulatory Affairs Professional at Siemens Healthineers!
Regulatory Affairs Professional – Siemens Healthineers
About Siemens Healthineers
Siemens Healthineers is a leading global medical technology company that offers a wide range of innovative products and services in the field of healthcare. With a strong focus on technology and research, Siemens Healthineers is dedicated to improving patient outcomes and enhancing the overall efficiency of healthcare delivery.
Job Description
Job ID: 400966
Company: Siemens Healthcare Private Limited
Organization: Siemens Healthineers
Job Family: Quality Management
Experience Level: Experienced Professional
Full Time / Part Time: Full-time
Remote vs Office: Office/Site Only
Contract Type: Permanent
Responsibilities:
- Regulatory Compliance:
- Ensure adherence to regulatory requirements for In Vitro Diagnostics in accordance with MDR 2017.
- Stay updated on regulatory changes and effectively communicate their impact on the organization.
- Geographical Oversight:
- Responsible for regulatory affairs activities in India, with extended coverage to neighboring countries and ASEAN.
- Navigate regulatory landscapes to facilitate product registrations and approvals.
- Certification and Qualification:
- Knowledgeable in the acquisition of CE Marking, USFDA approval, and WHO qualification for IVD products.
- Facilitate and oversee the regulatory processes for obtaining necessary certifications.
- Liaison and Collaboration:
- Build and maintain effective relationships with regulatory bodies, including but not limited to Gujarat FDCA, CDSCO, ICMR, and NIB.
- Collaborate with internal teams to ensure regulatory compliance throughout the product life cycle.
- Documentation and Submission:
- Prepare and submit regulatory documents, ensuring accuracy and completeness.
- Manage regulatory submissions and responses to inquiries from regulatory agencies.
- Risk Management:
- Identify and assess regulatory risks associated with IVD products.
- Develop and implement strategies to mitigate regulatory risks.
- Training and Awareness:
- Conduct training sessions for internal teams to enhance regulatory awareness.
- Keep the organization informed about changes in regulations and their implications.
Qualifications:
- Bachelor’s or Master’s degree in a relevant field (Life Sciences, Biotech, Pharmacy or Regulatory Affairs, etc.).
- Minimum 6-8 years of experience in Regulatory Affairs, with a focus on In Vitro Diagnostics for the last 3 years.
- Thorough knowledge of MDR 2017 and other relevant regulations.
- Experience in acquiring CE Marking, USFDA approval, and WHO qualification will be highly preferred.
Skills:
- Excellent communication and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Detail-oriented with a focus on accuracy in documentation.
- Ability to work collaboratively in a cross-functional team environment.
To apply for this position, please visit the Siemens Healthineers careers page.
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