Principal Regulatory Affairs Specialist

September 8, 2017 | Lexington, MA (USA) | Quality Assurance and Regulatory Compliance

The Principal Regulatory Affairs Specialist works as a high level independent contributor and is responsible for supporting the development and implementation of the overall objectives and long-range regulatory strategies that impact the introduction of new products, the market status of existing products and the development and maintenance of systems and processes that assure compliance with regulatory requirements. May serve as a mentor to help develop regulatory depth and knowledge within the regulatory department.

 Key Responsibilities: 

  • Work with senior management by overseeing the activities required to insure that products manufactured and/or distributed by Sekisui Diagnostics are in full compliance with U.S. and all applicable international regulatory requirements.
  • Maintain current knowledge of the developments and changes to applicable laws, regulations and industry standards.
  • Develops and implements regulatory strategies for new and modified products.
  • Provides regulatory guidance and direction as a core team member on manufacturing and development teams, throughout the product life-cycle, and identifies/coordinates cross functional deliverables for submissions.
  • Prepares submissions to obtain and maintain global regulatory approvals of products.
  • Reviews and approves device labeling and advertising and promotional materials to ensure continued compliance to global regulations; leads the development of regulatory strategies for new claims, indications and therapies.
  • Reviews and approves product and manufacturing changes for compliance with applicable regulations.
  • Acts as company representative, developing and maintaining positive relationships with regulatory agency reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
  • Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
  • Provide regulatory representation on corporate-wide projects related to product development, design controls, design assurance, sustaining engineering and regulatory business systems.
  • Provide expertise and guidance in interpreting regulations and agency guidelines.
  • Provide support for acquisitions, including due diligence and post-acquisition assessment and education.
  • Develop and maintain company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
  • Provide support for internal and Regulatory Agency audits
  • Build Quality into all aspects of job performance by maintaining compliance to all quality requirements. 

Requirements

  • Bachelor's degree, preferably in a scientific or technical discipline
  • Professional certification(s) preferred
  • 8+ years Regulatory Affairs medical industry experience
  • Demonstrated success in management of regulatory submissions activities
  • Combination product submission experience preferred
  • PMA submission experience preferred
  • Thorough understanding of global regulations
  • Strong technical knowledge of medical products
  • Strong technical understanding of relevant procedures, practices, and associated medical terminology
  • Thorough knowledge of product development process and design control
  • Excellent research and analytical skills
  • Ability to manage multiple projects
  • Ability to work and problem solve both independently and within a team.
  • Excellent written and oral communication, technical writing and editing skills
  • Strong interpersonal and influencing skills
  •  Proficiency with Microsoft Office, Adobe etc. 

Thank you for your interest in this position. Only those Applicants selected for an interview will be contacted.

 Principal Regulatory Affairs Specialist, Lexington

 

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