Regulatory Affairs Specialist

3 weeks ago

Hyderabad, Telangana, India Thepharmadaily Full time
Job Description

- Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing, and Operations
- Support the Global Operating Unit Regulatory Affairs function as the local representative, ensuring requirements are met
- Provide regulatory support for research and development activities and ensure compliance with Indian and other applicable regulations and policies

A Day in the Life:

- Support Design and Development Control activities with regulatory requirements, direction, tactics, and strategies.
- Work in a team environment with all organizational departments.

Job Responsibilities:

- Prepare, review, file, and support premarket documents for global registrations for assigned projects.
- Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.
- Represent Regulatory Affairs as a team member of product development projects from Concept through Commercialization.
- Review pre-clinical and clinical protocols and associated reports for submissions.
- Develop Regulatory Strategies for new or modified products.
- Monitor and provide information on regulatory environment changes.
- Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.
- Document and maintain communication with health authorities.
- Prepare internal documents for device modifications.
- Participate in health agency inspections and notified body audits as necessary.
- Author and/or review regulatory procedures and update as necessary.
- Review change control documents and assess regulatory impact.
- Assist in the development/maintenance of regulatory files, records, and reporting systems.
- Review promotional material, advertising, and labeling for regulatory compliance.
- Ensure compliance with regulations for MEIC developed products raw materials and prototypes.

Minimum Qualifications:

- Bachelors degree in Medical, Mechanical, Electrical Life Science, or other healthcare-related majors.
- 4-7 years of experience in a Regulatory Affairs role in the medical device and/or pharmaceutical industry.
- Good understanding of regulations and policies issued by India, US FDA, and EU, with the ability to interpret international regulatory requirements.
- Excellent written, organizational, and communication skills.
- Strong attention to detail and ability to handle multiple tasks.
- Proficient in English (reading, writing, and speaking).
- Good planning skills and the ability to work under pressure.
- Good learning attitude.

Nice to Haves:

- Excellent communication and interpersonal skills.
- Self-motivated and positive attitude.
- Ability to quickly establish credibility with all levels of the customer base

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