RegDesk is a leading organization in the medical device regulatory domain, offering expertise and solutions to help businesses navigate the complexities of medical device regulations. The company specializes in regulatory intelligence, providing strategic insights into regulatory updates and submissions for medical devices globally. RegDesk is seeking a passionate and skilled individual to join their team as a Regulatory Intelligence Associate to contribute to their continued success.
Job Responsibilities:
As a Regulatory Intelligence Associate, your key responsibilities will include:
- Global Medical Device Registration: The candidate will be responsible for preparing and managing submissions for international medical device registration.
- Regulatory Expertise: Staying up-to-date with global regulations for medical devices and ensuring compliance with the latest industry standards.
- Data Summarization: Summarizing regulatory data clearly and concisely for various stakeholders.
- Regulatory Research: Sourcing and synthesizing relevant regulatory laws and guidelines to inform decisions.
- Monitor Regulatory Changes: Keeping an eye on regulatory updates and communicating important changes to the team.
- Communication: Collaborating with international affiliates and the regulatory intelligence team to ensure seamless communication and alignment.
- Proactive Attitude: Bringing a high-energy, proactive approach to the team, contributing positively to team efforts and goals.
Qualifications:
- Educational Background: M.Pharm RA/MD or Masters in Medical Devices or equivalent.
- Experience: A minimum of 1-5 years of experience in medical device regulations and submissions is required.
- Technical Skills:
- Strong knowledge of global medical device registration and submission processes.
- Expertise in international regulations for medical device compliance.
- Excellent communication skills in English, both written and verbal.
- Personality Traits:
- Team player with a go-getter attitude and enthusiasm for proactive problem-solving.
- Detail-oriented with the ability to summarize complex regulatory data effectively.
Skills:
- Regulatory intelligence and research
- Global medical device registration expertise
- Knowledge of international regulations (FDA, CE, ISO)
- Effective data summarization and analysis
- Strong communication and collaboration skills
- Team-oriented mindset with a proactive attitude
- Proficiency in the English language, especially in writing regulatory reports
How to Apply:
Interested candidates can apply by sending their resumes to apurva.bhardwaj@regdesk.co. Make sure to mention your relevant experience and qualifications in your application to showcase your expertise in regulatory intelligence and medical device regulations.
Location: Mohali, India (On-Site Only)
