Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Minneapolis, Minnesota
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REGULATORY AFFAIRS SPECIALIST II
North America, USA, Minnesota, Minneapolis
This position provides regulatory expertise for the Smiths Medical site based in Plymouth, MN, and will also provide regulatory advice and assistance to other Smiths Medical site representatives.
Duties and Responsibilities
* 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.
* 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.
* Keep abreast of new and changing regulatory requirements.
* 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.
* Prepare and submit 510(k) Premarket Notification, PMA, IDE, and Design Dossier submissions as directed.
* Ensure regulatory compliance to FDA and international regulations.
* Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
* 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).
Required Skills and Experience
* Bachelor's degree in Science or Engineering (or related field) from an accredited college or university. A minimum of Five to Seven years direct experience in quality/regulatory affairs (preferably in the medical device/drug or biomedical area).
* Knowledge and ability to review and approve ECO's and corporate SOP's.
* Sound knowledge and understanding of how IDE regulated clinical studies are performed.
* 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.
* 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.
* 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 arbitrate conflicts between departments regarding quality and regulatory issues.
* Ability to influence and lead department members and peers as well as work effectively as a team player.
* Ability to develop and implement short and long range department goals in reference to Regulatory Affairs.
* Ability to analytically assimilate regulatory information and updates and effectively convey these principals to appropriate departments.
* Ability to travel from time to time to effectively carry out these duties.
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).
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