Job Title: Regulatory Affairs Specialist (Work From Home) at Akkodis
Experience: 0-1 Years (Freshers and Experienced)
Salary: Rs. 22,000 per month
Company Overview:
Akkodis is a global digital engineering company and Smart Industry leader, providing Talent, Academy, Consulting, and Solutions services to drive digital transformation. With 50,000 experts across 30 countries, Akkodis empowers clients with innovative technologies and deep sector knowledge.
Job Description:
As a Regulatory Reporting Specialist at Akkodis, you will play a crucial role in ensuring compliance with regulatory requirements for medical devices and pharmaceutical products. Your responsibilities will include:
- MedWatch Reporting: Generate and submit MedWatch reports following regulatory guidelines.
- Regulatory Expertise: Proficiency in 21CFR Part 803 regulations for medical device reporting.
- Complaint Management: Manage regulatory reporting processes for adverse events, product problems, and complaints.
- Regulatory Compliance: Assess complaints and determine appropriate actions to meet regulatory standards.
- Cross-functional Collaboration: Collaborate with teams to streamline regulatory reporting workflows and enhance efficiency.
Key Skills and Qualifications:
To excel in this role, you should possess the following skills and qualifications:
- In-depth knowledge of regulatory reporting requirements, especially in healthcare or pharmaceutical industries.
- Familiarity with MedWatch reporting systems and procedures.
- Strong understanding of 21CFR Part 803 regulations.
- Experience in complaint management and adverse event reporting.
- Excellent communication and collaboration skills for remote, cross-functional work.
- Ability to analyze complex data and interpret regulatory guidelines accurately.
- Relevant educational background in regulatory affairs, pharmacovigilance, or a related field.
Education: B Pharm / M Pharm / PharmD / Bsc / Msc / Any life sciences graduates
Work Location: Work From Home
Application Note:
Join Akkodis as a Regulatory Affairs Specialist and contribute to shaping the future of digital healthcare. We welcome freshers and experienced professionals alike. Apply now to be part of our dynamic team!