Regulatory Affairs Specialist Jobs in Chennai - Smiths Medical
Job Description
Duties & Responsibilities
Technical Knowledge And Skills
- Provide regulatory advice and assistance to other Smiths Medical site representatives. Prepare and submit regulatory submissions to Regulatory Authorities e.g. the FDA, (for PMAA, IDE, 510(k) Notification); and to European notified body to support distribution and marketing objectives set.
- Ensure regulatory compliance to FDA and international regulations.
- Prepare and submit 510(k) Premarket Notification, PMA, IDE, and Design Dossier submissions as directed.
- Create and maintain Essential Requirements Checklists, CE Technical Files and Declarations of Conformity for all products bearing the CE Marking.
- Prepare Annual PMA Report and associated PMA Supplements as required.
- Regulatory representative on new product development teams.
- Review and approve ECO's for product changes and/or modifications related to manufacturability and/or material modifications. Ensure compliance to existing regulatory submissions.
- Review and approve technical literature (labeling, IFU’s, manuals, patient guides, etc.), sales and marketing literature,and reimbursement literature related to company products.
- Review and approve Pre-launch product submissions to ensure compliance with internal company requirements and compliance with regulatory requirements.
- Keep abreast of new and changing regulatory requirements.
- Update RA procedures as needed to ensure Smiths Medical is in compliance with new and changing regulatory requirements.
- Inform project teams of new and changing regulatory requirements.
- This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
- Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
Technical Knowledge And Skills
- University Degree (BA degree) required
- 0-3 years related work experience in quality/regulatory affairs (preferably in the medical device/drug or biomedical area).
- Excellent working knowledge of up-to-date domestic, international, and company regulatory compliance requirements and operating procedures. Including but not limited to FDA, PMAA, IDE, 510(k) Notifications, Medical Device Directive, and European Standards.
- Sound knowledge and understanding of how IDE regulated clinical studies are performed.
- Knowledge and ability to review and approve ECO's and corporate SOP's.
- Sound knowledge and understanding of company products as they relate to medical device law and international medical devise requirements.
- Knowledge and ability to develop, review and approve technical literature as it relates to product specifications and that is consistent with domestic and international regulations.
- Effective facilitation skills to motivate engineers, marketing personnel and/or clinical staff to deliver information related to submission preparation and/or direct product literature review, both technical and sales marketing pieces.
- Excellent verbal, written, and presentation communication skills.
- Education requirements can be obtained through an educational institution or gained through equivalent work experience
- Ability to negotiate critical points regarding devices to the favor of corporate objectives, (i.e. to reduce costs associated with regulation and/or marketing objectives
- Ability to analytically assimilate regulatory information and updates and effectively convey these principals to appropriate departments.
- Ability to develop and implement short- and long-range department goals in reference to Regulatory Affairs.
- Ability to influence department members and peers as well as work effectively as a team player.
- Ability to arbitrate conflicts between departments regarding quality and regulatory issues.
- Direction is usually stated in general terms of goal or objectives taking several weeks or months to achieve.
- Prepares complex regulatory strategies for products the company intends to develop and market.
- Develops and implements plan to improve department efficiency.
- Controls/constraints over position are the following: FD&C Act, current and past precedence for device file/no files decisions, other current GMP practices employed by the company, and company SOP.
- Determines if information contained in engineering change orders is adequate and consistent with domestic and international submissions.
- Develops and/or participates in the development of policies and procedures related to clinical studies.
- Position has some latitude in which to determine method of preparing product submissions and applications.
- Position has some latitude in methodology on determining how to handle negotiations with agency staff related to product submissions.
Job Particulars
Role others
Education BA
Who can apply Freshers and Experienced (0 to 3 Years )
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id938277
Job Category Others
Locality Address
State Tamil Nadu
Country India
About Company
About Us
Smiths is always looking for curious minds. For new colleagues who want responsibility and relish a challenge. Those who would like to use their talents to help make the world safer, healthier, more efficient and more connected.
We're proud that we've been helping propel the human world forwards during our 160 year history of innovation. By looking at things differently. By adapting and never standing still. And by always thinking big.
Today we're an aligned global business of five divisions and around 22,000 colleagues, that touches the lives of millions every year across five vibrant global markets.
In Smiths Medical, one of the five divisions of Smiths Group, we touch the lives of millions of people every day. Our colleagues are focused on providing innovative, lifesaving solutions for patients around the world.
So whether you're an experienced professional or just starting out on your career, our global scale and focus on growth means great career opportunities for the right colleagues. There's never been a better time to join Smiths. And help us create the future.
Smiths is always looking for curious minds. For new colleagues who want responsibility and relish a challenge. Those who would like to use their talents to help make the world safer, healthier, more efficient and more connected.
We're proud that we've been helping propel the human world forwards during our 160 year history of innovation. By looking at things differently. By adapting and never standing still. And by always thinking big.
Today we're an aligned global business of five divisions and around 22,000 colleagues, that touches the lives of millions every year across five vibrant global markets.
In Smiths Medical, one of the five divisions of Smiths Group, we touch the lives of millions of people every day. Our colleagues are focused on providing innovative, lifesaving solutions for patients around the world.
So whether you're an experienced professional or just starting out on your career, our global scale and focus on growth means great career opportunities for the right colleagues. There's never been a better time to join Smiths. And help us create the future.
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