Connecting to LinkedIn...

W1siziisijiwmtcvmdyvmjmvmdgvmzmvmdevoda2l3byb2ply3r1cy1iyw5uzxiucg5nil0swyjwiiwidgh1bwiilcixodgwedmymcmixv0

Job Information

Regulatory Affairs Manager

Information About this Role

Regulatory Affairs Manager

A highly attractive opportunity to join a fast-growing medical device company active in one of the most promising fields of medicine in a very collaborative atmosphere in an open-minded environment
 

Summary

 

  • Taking an active role in developing regulatory strategies for new products.
  • Management of regulatory submissions to regulatory authorities for the company’s products.
  • Ensuring assigned regulatory activities associated with clinical studies are fulfilled.
  • Management of routine regulatory activities including clinical evaluation, safety and vigilance reporting and post market surveillance reporting.
  • Maintenance of existing global regulatory approvals.
  • Supervision of direct regulatory team members to ensure timely and successful achievement of regulatory goals.

 

Principal Responsibilities

               

  • Manage the preparation of global regulatory submissions including but not limited to PMA/CE Mark/IDE submissions, IDE/PMA supplements and amendments, EU Technical File submissions, EU Substantial Change Notifications, EU Clinical Evaluation Reports, Post Market Surveillance Reports and Annual Reports.
  • Manage the review process for regulatory submissions ensuring effective communication with the reviewers and within the company to ensure that queries are addressed in a timely and effective manner.
  • Compile/review regulatory documentation to support global pre and post market clinical study submissions.
  • Manage regulatory projects to ensure company milestones are achieved.
  • Support the preparation of clinical reports from IDE, OUS and Post Approval clinical studies.
  • Review and approve product labelling changes, promotional literature and marketing materials prepared by the Company and its distributors.
  • Provide input to regulatory aspects of design control, change control, non-conforming process.
  • Participate as a Clinical Project team member to provide regulatory oversight of clinical operations including provision of safety reporting and vigilance support.
  • Provide a regulatory interface to the company’s clinical and commercial operations.
  • Develop and advise on regulatory strategies for existing and changing products in collaboration with R&D, Manufacturing and Quality Assurance departments, as appropriate.
  • Maintain knowledge of current regulatory environment in relevant markets to ensure that information is adequately communicated throughout the company relating to changes in the regulatory environment.
  • Responsibility for assisting in implementing regulatory requirements in accordance with US Regulations, ISO 13485, MDD 93/42/EEC, MDR 2017/745 and other jurisdictions as required.
  • Assist with training of company employees in relevant areas of regulatory affairs.
  • Provide regulatory oversight of customer complaint handling procedure.
  • Manage assigned aspects of the Quality System, as required.
  • Manage regulatory resources to ensure timely and successful achievement of regulatory goals.

 

Education & Training

Bachelor’s or Master’s degree in science, pharmacy, engineering or life-sciences related field

 

Experience

  • Minimum 8 years’ experience in regulatory affairs, ideally with Class III cardiovascular medical devices.
  • Previous experience in drug/device combination product filings highly desirable.
  • Understanding of regulatory strategy and determination of documentation requirements, timelines, budgets and filing options.
  • Ability to work to manage busy workload encompassing several active projects.
  • Excellent oral and written communication skills. Negotiation abilities to identify and resolve issues; highly organised.
  • Prioritise own work load and the work load of the project team to achieve project deliverables.
  • Willingness and availability to travel on company business.
  • Proficient in all Microsoft Office applications.
  • Experience of working with the following standards: ISO 13485; ISO 14155; 21 CFR 820;
    21 CFR 814; 21 CFR Parts 50, 54, 56, 812; MDD; EU MDR; ICH GCP.
  • Quality management system experience.
  • Experience of CAPA, Auditing and Risk Management (including FMECA).
 

Contact in confidence: +442038000513 or John@projectusconsulting.com