Dear Job Seekers,
MME Introduce, excellent job opportunity for your bright career. Find below the details and revert back if you are from same industry and taking care of similar job responsibility. Only Serious job seekers need to share their application.
Designation: – Regulatory Affairs Specialist
Industry: Manufacturing/Pharmaceutical
Qualification: Bachelor Degree in Science or equivalent; Masters Degree will be an asset.
Location: Bangalore
Working days: 5 Days
Working Timings: USA – Male 2 to 11pm & Female – 6am – 3pm
Position Purpose:
The purpose of this job is to file necessary applications and handling all national and international interactions pertaining to the regulatory process for products requiring regulatory approval. Assists in developing technical files to ensure regulatory compliance. Assists in identifying medical device/ drugs regulations for various geographies. Reports to the Director of Regulatory Affairs. Improve and maintain the Quality Management System and strategies for maintaining compliance with established standards and agency guidelines.
Summary of Responsibilities:
Support product registration and regulatory submissions and approvals to introduce new products in the US, EU, Canada, Australia and other markets.
Assist the VP of QA/RA and Director of Regulatory Affairs in developing and implementing quality strategies. Improve quality system / procedures to maintain compliance with ISO 13485:2003. Coordinate and support internal and external audit. Maintain quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of the products conform to established standards and agency guidelines. Provide support for quality systems improvements, and business process improvement initiatives.
Key Responsibilities:
- Support product’s registration and regulatory submissions, including but not limited to FDA 510(k), Drugs Dossiers, Technical Files, Canadian Drug/NHP and Device License Applications, and internal “Letters to File”.
- Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
- Review and sign off on product and manufacturing changes for compliance with applicable regulations.
- Create and review of documents used in good manufacturing practices; monitor audits of production and quality control areas.
- Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance and effectiveness.
- Draft, modify and record regulatory SOPs, WIs, etc. pertaining to regulatory requirements
- Manage document control and provide oversight of related quality systems such as training and other electronic quality systems to ensure effectiveness.
- Manage non conformance, corrective action preventive actions and deviation.
- Participate with peers in the formulation of overall direction, processes, systems and talent development for the Quality organizations.
- Create, review and approve test protocols (as needed) to support regulatory submissions.
- Develop and support in implementation of departmental and divisional policies and procedures.
- Create Test Reports and Test Protocols for the testing done in-house.
- Support product registration and regulatory submissions and approvals to introduce new products in the US, EU, Canada, Australia and other markets, typically for Drugs, and Class I and II Medical Devices.
- Manage and renew all the regulatory registrations.
- Supervise direct reports if any
- Other duties as assigned
KNOWLEDGE/EDUCATION
- Knowledge of FDA medical device and drug regulations, guidance, and import/exports requirements.
- Knowledge of European Medical Device Directive, Medical Device Regulations and of applicable guidance documents (MEDDEV, NBMED, etc.)
- Knowledge with medical device labeling and promotional requirements.
- Strong understanding of the quality system and ISO13485 regulations
- Experience with UDI requirements (FDA and Europe) is highly desired
SKILLS/COMPETENCIES
- Proficient in timely review of technical and clinical data.
- Proficient in FDA and international regulations (e.g. EU and Canada)
- Good presentation skills.
- Excellent computer skills – proficiency with MS Office products
- Strong written and oral communications skills; strong technical writing skills.
- Detail oriented and self-motivated.
- Ability to write clear, concise, and well thought out technical documents.
- Able to manage moderately complex problems/projects by exercising independent decision making and analytical thinking skills
- Ability to work under minimal supervision and independently.
- Must be able to work in a timeline-driven environment.
- Must be flexible with working hour
NOTE: We are not having any registration charges Or service fee from job seekers but don’t entertain unwanted job seekers who are not serious for their job change. Expecting genuine application to avoid fraud & Fake candidates.
If Interested please revert back with your updated cv and photograph at [email protected] or for more details you can contact us at 9871008190
Best Regards
Ms. Anamika
MM Enterprises