Posted in Compliance 30+ days ago.
Type: Full Time
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SENIOR REGULATORY AFFAIRS SPECIALIST
Location
North America, USA, Minnesota, Minneapolis
Job Reference
MEDNA01094
Job Function
Reg Affairs & Quality Assurance
Job Description
Smiths Medical is currently hiring a Senior Regulatory Affairs Specialist in Minneapolis, MN.
The Senior Regulatory Affairs Specialist will provide regulatory expertise. This position will also be required to provide regulatory advice and assistance to other Smiths Medical site representatives. This will require travel from time to time to effectively carry out these duties. Additionally, this role will 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 objective set by divisional and corporate staff.
Smiths Medical has a positive impact on someone s life around the world every minute of every day. In fact, over 240 people every minute benefit from a Smiths Medical product. Join us and grow your career while being a part of our continued success! We offer a fun, fast-paced, inspiring and collaborative work environment with opportunities to learn and contribute at all career levels. Innovation is part of who we are, with industry-leading products across a broad spectrum of medical device categories and a strong new product development pipeline. Duties & Responsibilities
* Prepare and submit 510(k) Premarket Notification, PMA, IDE, and Design Dossier submissions as directed.
* Review and approve Pre-launch product submissions to ensure compliance with internal company requirements and compliance with regulatory requirements. 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 ECO's for product changes and/or modifications related to manufacturability and/or material modifications. Ensure compliance to existing regulatory submissions.
* Regulatory representative on new product development teams.
* Prepare Annual PMA Report and associated PMA Supplements as required.
* Create and maintain Essential Requirements Checklists, CE Technical Files and Declarations of Conformity for all products bearing the CE Marking.
* Review and provide oversight of FDA Drug Listings, State Distributor Licensing among State Boards of Pharmacy, and Global Product Registration in support of Direct Reports.
* Review and approve product literature to ensure compliance with FDA and international submissions on file.
* Review and approve Pre-launch product submissions to ensure compliance with internal company requirements and compliance with regulatory requirements.
* Provide regulatory guidance on new product development and manufacturing changes to existing products.
* Review and approve engineering change orders (ECO's) ensuring compliance with FDA and international submissions on file.
* Inform project teams of new and changing regulatory requirements.
* Update RA procedures as needed to ensure Smiths Medical is in compliance with new and changing regulatory requirements.
* Direct the development of international master files for registration of product in international markets.
* 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.
Diversity & Inclusion
We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity. The Individual
* Bachelor's degree in Science or Engineering (or related field) from an accredited college or university. A minimum of Seven to ten years direct 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.
* Excellent verbal, written, and presentation communication skills. Proven effective leadership skills to guide, mentor, and develop staff members to perform under stress to meet or exceed project schedules and corporate filing deadlines.
* 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.
* 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.
* Sound knowledge and understanding of company products as they relate to medical device law and international medical devise requirements.
* Knowledge and ability to review and approve ECO's and corporate SOP's.
* Education requirements can be obtained through an educational institution or gained through equivalent work experience.
Salary & Benefits
In addition to a competitive compensation package, Smiths Medical offers a comprehensive benefit package including Medical, Dental, Vision, 401K and much more! About Smiths
At Smiths we apply leading-edge technology to design, manufacture and deliver market-leading innovative solutions that meet our customers' evolving needs, and touch the lives of millions of people every day. We are a FTSE100, global business of around 23,000 colleagues, based in 55 countries. Our solutions have a real impact on lives across the planet, enabling industry, improving healthcare, enhancing security, advancing connectivity and supporting new homes. Our products and services are often critical to our customers operations, while our proprietary technology and high service levels help create competitive advantage.
At Smiths Medical, we are passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. We are a leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world s healthcare markets.
Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services, our products are found in hospital, emergency, home and specialty care environments and are used during critical and intensive care, surgery, post-operative care and for supporting managing chronic illness.
Smiths Medical is an EEO/AA Employer/Vet/Disabled
If you require assistance with our online job submission process, please contact our Talent Acquisition team at 855-754-5032 to request an accommodation. Additionally, Smiths Medical invites interested deaf and hard of hearing applicants to use Video Relay Service (VRS).