AM/DM (Documentation)

1 week ago


Faridabad, India Poly Medicure Ltd Full time

Job Description-:


Responsibilities:


• Conduct thorough reviews of design history files (DHF) for medical devices.

• Identify and correct inconsistencies or gaps in documentation.

• Ensure all design files comply with FDA regulations, EU MDR and ISO standards.

• Collaborate with R&D, quality assurance, and regulatory teams to update and maintain documentation throughout the product lifecycle.

• Assist in preparing for audits and regulatory inspections by maintaining robust documentation practices.

• Train and guide team members on best practices for DHF management.


Required Skills and Qualifications:


• Masters in pharmacy, Bachelor’s degree in Engineering, Biomedical Sciences, Regulatory Affairs, or related field.

• Atleast 5 years of experience in medical device industry in managing and reviewing design history files.

• Proficient understanding of FDA regulations, ISO 13485, EU MDR and other relevant standards.

• Strong analytical and problem-solving skills.

• Excellent communication and collaboration abilities.

• Proven ability to manage multiple projects and meet deadlines.

• Detail-oriented with a high level of accuracy in documentation.

• Strong interpersonal and communication skills, capable of working collaboratively in a cross-functional team.

• Proficient in Microsoft Office and experience with electronic document management systems



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