Mgr, Regulatory Affairs, Medical Device SME

📁
Consulting
📅
20004998 Requisition #

Summary:           

 

Responsible for leadership of major assignments and client relationships.  In consultation with the line manager, responsible for organizing and managing project teams and for the quality and timeliness of assignments. Provides advice and assistance to clients and other associates in areas of expertise. Ensures that the various project related tasks are completed in conformity with all Company policies, Standard Operating Procedures, and governmental regulations.  Contributes to business development for regulatory functions.

 

 

Essential Functions:

 

  1. Contributes to planning for GRC function in assigned region/country.

 

  1. Responsible for day to day management of project teams and projects. Line management responsibilities for staff members.  For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.  Approves courses of action on salary administration, hiring, corrective action, and terminations.  Reviews and approves time records, expense reports, requests for leave, and overtime.  Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.

 

  1. Acts as a representative of the regulatory department with other departments.

 

  1. Supports business development, including generation of repeat business from existing clients and proposal development.

 

  1. Develops, reviews, and monitors project budgets; reviews client invoicing.

 

  1. Monitors personal utilization and utilization of direct reports.

 

  1. Acts as a key point of contact for clients and regulatory authorities.

 

  1. Provides regulatory advice to Company associates.

 

  1. Conducts regulatory research on projects as needed.

 

  1. Provides strategic and operational advice to clients.

 

  1. Arranges, leads, and reports on client and regulatory agency meetings.

 

  1. Writes clinical trial and product registration dossiers, clinical reports, and other medical documents.  Manages project teams and preparation of regulatory submissions for conduct of clinical trials, product registration, and post approval maintenance activities.

 

  1. Acts as a resource for technical knowledge.

 

  1. Participates in quality improvement efforts to increase overall operational efficiency.

 

  1. Contributes to the building of regulatory systems and infrastructure needed for GRC
  2. Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees.

 

  1. Develops solutions to complex problems.

 

  1. Provides internal training in appropriate areas of expertise to other departments.

 

 

Other Responsibilities:

 

Performs other work-related duties as assigned.  Minimal travel may be required (up to 25%).  

 

Note:  If there are additional responsibilities that are specific to an individual employee, department, country, or other grouping, please use the Job Description Addendum Template.

Requirements:

 

BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field.  Moderate pharmaceutical/medical device related experience.  Moderate experience in regulatory.  Demonstrated experience in contributing to the preparation of regulatory submissions including electronic submissions.  Experience working in an independent office environment, and in a complex multi-process oriented environment in general preferred.  Comprehensive regulatory knowledge and understanding of pharmaceutical and or medical device product development.  Excellent customer service and interpersonal skills, with the ability to work both as a team member and independently.  Excellent written and verbal communication skills.  Good quality management and budgeting skills.  Good people management, project management, problem-solving, and decision-making skills.  Computer literacy in MS Word, Excel, and PowerPoint.  Ability to interact with staff from multiple departments and offices to establish project standards.  Good initiative, adaptability, and pro-activity.  Good attention to detail, flexibility, and open to suggestions.

 

 

Disclaimer:

 

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.  Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.


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