Specialist,Regulatory Affairs

📁
Quality
📅
191CK Requisition #

JOB SUMMARY:

The Regulatory Affairs Specialist is responsible for implementing the global introduction and continued approval/licensure of new and revised products. They provide subject matter expertise and are responsible for advising and guiding the local organization on regulatory topics. They are also the primary liaison to Marketing and Sales groups with regard to regulatory requirements for marketing communications and other customer-facing communications. These activities will all be done in full compliance with U.S. and international regulatory requirements.

 

 

ESSSENTIAL/PRIMARY DUTIES:

  • Prepare U.S. FDA and Health Canada submissions for new products and product changes as required to ensure timely approval for market release and in accordance with applicable regulations, standards and guidance.

  • Lead and provide guidance to work teams comprised of senior engineering and marketing personnel with regard to regulatory planning and execution.

  • Conduct post-market surveillance such as literature reviews, clinical study reviews, etc.

  • Assist with product hazard analyses and recall assessments. Coordinate and lead Field Corrective Action (FCA) and Recall Strategy as needed.

  • Advise technical, marketing and sales teammates on regulatory requirements (e.g., Design Controls, CE Marking, IDE, IRB, Labeling, and Promotion).

  • Provide guidance and review of product labeling, promotional material, change control and other related product documentation.

  • Maintain database(s) for the worldwide regulatory status of products.

  • Maintain regulatory affairs product files to support compliance with requirements and standards.

  • Assist with regulatory audits from partners and external regulatory agencies

  • May generate technical files and declarations of conformance

  • Maintain the company’s Medical Device Listing and Device Establishment registration forms.

  • Interpret, execute and recommend modification to internal guidelines, work instructions, procedures.

  • Support the development and implementation of the regulatory department’s policies and procedures and strategic objectives.

  • Maintain current knowledge of the developments and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals within the company and sector.

  • Serves as an internal auditor in order to assure regulatory compliance across all product lines. 

  • Interpret new and existing regulatory requirements as they relate to our sector products and initiate actions to assure compliance to these regulations.

  • Participate as the regulatory representative on project teams and provide guidance and direction to ensure FDA and international product registration/licensing requirements are addressed and met prior to commercial release.  This would include FDA subchapter J on radiological device requirements (Buffalo Grove facility).

  • In collaboration with Regulatory management, lead submission activities for devices in gaining required clearances through the processes of IDE’s, 510(k) s, PMA’s, CE marking.

  • Assist in various projects as assigned.

 

SECONDARY DUTIES:

  • Support design verification and validation including usability risk management study planning and report generation.

  • As needed, review and analyze product complaints for appropriate domestic and international filings as part of product post-market surveillance.





EDUCATION and/or EXPERIENCE:


  • BA/BS degree in engineering or life sciences

  • At least five years of progressive experience in domestic/international regulatory submissions, design control systems and/or regulatory compliance.

  • Experience with product registration requirements US, Canada, EU and other major international markets i.e. China, Australia, Brazil, Saudi Arabia, etc.

  • Experience in the preparation of 510(k) submissions

  • Experience with development and post market support of Class I and II Medical Devices


 


COMPETENCY/SKILL REQUIREMENTS:


  • This position assures company compliance to all pertinent United States FDA, state, and international regulatory requirements which are applicable to the design, manufacture and distribution of medical and diagnostic devices.

  • Knowledge of international quality and product standards for electro-mechanical equipment (e.g. ISO14971, ISO13485, EN60601, IEC62304, etc.)

  • Excellent written and oral communication

  • Strong project management and organizational skills.

  • Excellent verbal and written communication skills.

  • Strong analytical and problem solving skills.


SUPERVISORY RESPONSIBILITIES:

May supervise Returned Goods Technicians.  There would typically be less than 5 direct reports if applicable (Buffalo Grove facility).


 


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