Custom Search - Logo


VP Regulatory Affairs

Twitter Facebook
Apply
Location
MN
Job Type
Direct Hire
Date
Nov 27, 2018
Job ID
2642430
Our mid-sized client is adding a Vice President of Global Regulatory Affairs to their team! The VP Regulatory will have multi-site responsibility for developing and leading the regulatory and technical communication strategy to support the product lifecycle of companies products from product development through commercialization.  Will provide regulatory insight (raising potential issues/concerns) on business matters, establish and maintain effective relationships with regulatory bodies such as the FDA, ensure regulatory compliance, and oversee global regulatory submissions and registrations. Improve regulatory intelligence to ensure seamless integration of new requirements. Provide oversight of all technical communications intended customers, including user manuals, instructions for use, product labeling and on-line help. Effectively collaborate with R&D, Marketing, Quality, Clinical, Operations and Medical Affairs to ensure regulatory compliance.

 

Your role with the company:

 

 

 

 

 

 

 

 

  • Provide overall leadership and direction to the regulatory and technical teams (3 direct reports and 7 indirect).
  • Collaborate with cross-functional stakeholders to develop regulatory strategies, which will creatively position innovative products for expeditious review/approval at regulatory agencies around the world. (E.g.;510(k) w/clinical or w/o clinical, IDE, PMA, CE Mark.).
  • Oversee the preparation of submission documentation to obtain various worldwide approvals to commercially distribute products.
  • Liaise and manage the relationship with the FDA and global regulatory authorities to professionally represent the company, and foster a collaborative relationship on the regulatory issues.
  • Provide senior management with critical risk assessments of strategic alternatives for regulatory filings.
  • Enhance and maintain an organization, which brings expert science, creativity and innovation; knowledge and regard of regulations; respect for teamwork and others; and a commitment to the success of the business.
  • Establish global regulatory affairs capability that will enhance the effectiveness of partnered product/business development and partner relationships.
  • Develop and grow the regulatory department in keeping with the needs of the company, and coach and mentor department staff.
  • Keep abreast of new developments in various regulations and advise senior management as necessary.
  • Monitor applicable regulatory requirements and global regulatory compliance.
  • Collaborate with Clinical, R&D, and Quality as required for regulatory compliance initiatives and sustainability of processes
  • Provide input to engineering teams to assure that worldwide regulatory requirements and standards are incorporated in the product development process and design/manufacture of products.
  • Collaborate with Quality in supporting Vigilance Reporting and Product Recall.

 

 

 

Desired Profile:

  • BS degree in Science or Engineering.
  • 15+ years of Regulatory Affairs experience in the medical device industry.
  • 10+years of management experience – regulatory submission activities in US; 510(k) and PMA including international registration, budgets, and personnel.
  • 10+ years people management and leadership experience.
  • Demonstrated project management skills in order to plan, conduct and implement system assessments
  • Demonstrated ability to interact with regulatory agencies to ensure effective approval of products
  • Working knowledge and experience with quality systems regulations and guidelines, ISO, cGMP, Medical Device Directive (MDD), Canadian Medical Device regulations, Japanese PAL and FDA regulatory requirements.
  • Ability to work in a cross-functional team environment
  • Strong attention to detail and the ability to handle multiple tasks.
  • Excellent organizational, computer and documentation skills and an ability to prioritize effectively.
  • Strong interpersonal skills including verbal and written communication.
  • Ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel.
  • Ability to travel both domestically and internationally.
    • Travel requirements are moderate. Travel to facilities would be about 2 – 3 days duration each trip with total travel expected to be less than 20%.
  • Prior experience working directly for or with a regulatory notified body.