Regulatory Affairs Manager

Smiths Medical • Minneapolis, MN 55401

Posted 6 days ago

Job Description

Job Description

This position provides regulatory expertise for the site and manages the work activities of the Regulatory Affairs team. The RA Manager will provide regulatory advice and assistance to other Smiths Medical site representatives. Develop and prepare regulatory submissions, i.e., 510(k) Premarket Notification, PMA, IDE, Design Dossier, and CE Technical Files. Review and ensure regulatory compliance of internal operational and project documentation involved in commercial product release for all assigned projects. Prepare, maintain and ensure regulatory documentation supporting engineering activity is filed and readily available, keeping electronic lists, registers and directories up-to-date. Develop regulatory strategy and departmental positioning with Director, Regulatory Affairs. Participate as regulatory representative on project teams, communicate regulatory requirements and strategy. Prepare and conduct meetings / teleconferences with external regulatory agencies as assigned. Assist with data entry and analysis as needed, ensuring data quality and validity. Ensure compliance with regulatory requirements at all times.

Duties and Responsibilities

Manage work activities of the RA team.

  • Ensure RA work activities are in line with overall project requirements and schedules. Monitor closely project activities ensuring RA team members have adequate resources to complete submission activities. Readjust work activities as needed.
  • Approve PTO consistent with requirements of overall project schedule requirements.
  • Conduct performance reviews of employees. Develop in conjunction with employee development plans. Collaborate with manager when finalizing employee development plans.
  • Conduct interviews and make hiring decisions for positions within RA Department.
  • Coordinate department activities consistent with overall business and project activities ensuring adequate RA resources are available and prioritized with these activities. Escalates conflicting needs of the business to manager for resolution.

Prepare and maintain regulatory submissions and files as required.

  • Prepare 510(k) Premarket Notification, PMAA, IDE, DMF, MAF, 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 and maintain communication to government regulatory agencies and notified bodies as needed.
  • Review and coordinate preparation of Pre-launch checklists for new and existing products to ensure compliance with internal company requirements and compliance with regulatory requirements. Work with project teams to ensure information is complete and follow-up as needed.
  • Assist Corporate Registration Unit as necessary to ensure information regarding products is readily available to unit personnel. Provide assistance and direction as needed.
  • Maintain all regulatory files ensuring documentation, registers, directories and lists are complete and up-to-date.

Review and ensure regulatory compliance of internal operational and project documentation involved in commercial product release for all assigned projects.

  • Review, edit and approve label reviews.
  • Review, edit and approve operational engineering documentation (i.e. ECO review).
  • Participate as Regulatory Representative on project teams
  • Review, edit and approve for project documentation as the active regulatory representative on project teams.
  • Monitor project time-lines and assist in coordination of timely regulatory processes, documentation.
  • In collaboration with senior regulatory representative, prepare and communicate project regulatory strategy.
  • Assist with literature reviews and preparation of literature summaries.
  • Manages work activities of the RA team. Actively participates in the hiring of staff for the RA department. Evaluates employee performance of all direct reports.
  • Provides recommendations for merit and bonus increases. Establishes bonus objectives in conjunction with Manager for employees eligible for bonuses.
  • 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

Technical Knowledge and Skills:

  • Bachelor's degree in Science or Engineering (or related field) from an accredited college or university required. Seven to ten years direct experience in 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 company products as they relate to medical device law and international medical device requirements.
  • Sound knowledge and understanding of how IDE regulated clinical studies are performed.
  • Effective facilitation skills to motivate engineers, marketing personnel and/or clinical staff to deliver information related to submission or clinical protocol preparation.
  • Excellent interpersonal skills to interface with project team members and able to contribute to the overall success of the team.
  • Excellent verbal, written, and presentation communication skills.


  • Ability to analytically assimilate regulatory information and updates and effectively convey these principals to appropriate departments.
  • Ability to critically analyze information as it relates to regulatory submissions and clinical protocols.
About Us

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 worlds 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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