Regulatory Specialist
Cyient
Full time- 8+ years
- Not Disclosed
- Hyderabad, India
- Post Date: Apr 02, 2024
- End Date: Jun 02, 2024
- 8+ years
- Not Disclosed
- Hyderabad, India
- Post Date:Apr 02, 2024
- End Date: Jun 02, 2024
Skills:
- Operations
- Regulatory Affairs
- Management
Job Description:
Responsibilities
- Understands regulations, follows complex directions, and investigates regulations when clarification is needed.
- Develops a working knowledge of the medical device regulations applicable to the devices being supported including, but not limited to: registration, labeling, and post-market surveillance requirements.
- In alignment with applicable strategies/plans and with support of team members, determines appropriate documentation and testing required for registration of products and coordinates with functional team members to obtain and provide this information.
- Prepares, organizes, and coordinates data for submission to and manages correspondence with the regulatory agencies.
- Works with team members to conduct documentation reviews and change assessments including evaluation of effects of regulatory, design, and manufacturing changes, and helps determine required regulatory action (e.g. submissions, notifications).
- Assists in development, organization, and application of labeling (e.g. instructions for use, marketing materials, package labels, etc.), and may review and provide feedback on labeling and advertisement/promotional material to assure regulatory compliance.
- Provides regulatory perspective to cross-functional teams (e.g. product development, risk management) to assure products are compliant with relevant US and international medical device standards, codes and regulations.
- Reports relevant regulation and standards changes and helps determine impact and/or appropriate action.
- Assures regulatory compliance and content accuracy of technical documentation and submissions.
- Hands on EU-MDR, 510K, ISO14971:2019, RA Files, IFU, Regulatory submissions
- Develops an expertise of the medical device regulations for assigned products.
- Determines applicable strategies /plans for products and works with functional and cross-functional team members to create, obtain, and provide this information.
- Provides regulatory perspective and expertise to cross-functional teams (e.g. product development, risk management) to assure products are compliant with relevant US and international medical device standards, codes and regulations.
- Reports relevant regulation and standards changes, determines impact and takes appropriate action.
- Ensures regulatory compliance of products and processes through participation in process updates.
- Bio-compatibility knowledge with Standard: 10993-1:2023,Sample Rationalization/Equivalency, Bio comp Evaluation Plan, Chemical Characterization , Biological safety of device End OF Life Evaluation, Gap assessment with latest standard
- Supports internal and external (third party) audits as required.
Qualification & Experience
- Bachelor of Science in science and/or engineering field
- 8 - 12years of regulatory experience in medical device industry (equivalent industry/educational experience may be considered)
- Thorough working knowledge of applicable FDA, ISO, EU and/or other region-specific medical device regulations, requirements, and standards.
- Experience in Orthopedics industry preferred.
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Salary
Not Disclosed
-
Role
Specialist
-
Area of Practice
- Regulatory Affairs
-
Experience
8+ years
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