Senior Regulatory Affairs Specialist

Smiths Medical   •  

Plymouth, MN

8 - 10 years

Posted 239 days ago

This job is no longer available.

SMNA00551

Job Description

  • Position provides regulatory expertise for the site. The incumbent 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. 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.

 

Duties and Responsibilites

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.
  • 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.

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 but not limited to FDA, Quality Systems Regulations, ISO13485, ISO14001, government occupational health and environmental regulations and statutes).
  • Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement
  • Review and approve engineering change orders (ECO's) ensuring compliance with FDA and international submissions on file.
  • Provide regulatory guidance on new product development and manufacturing changes to existing products. 
  • Review and approve Pre-launch product submissions to ensure compliance with internal company requirements and compliance with regulatory requirements.
  • Review and approve product literature to ensure compliance with FDA and international submissions on file. 
  • Direct the development of international master files for registration of product in international markets.
  • 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 andExperience


Technical Knowledge and Skills:

  • 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 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 salesmarketing 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.
  • 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.

Abilities:

  • 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 negotiate critical points regarding devices to the favor of corporate objectives, (i.e. to reduce costs associated with regulation and/or marketing objectives