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Director of Regulatory Affairs - 2019-011

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Location
Dane County, WI
Job Type
Direct Hire
Date
Apr 12, 2019
Job ID
2666407

My client is an industry leader that provides innovative life sciences solutions.
 
JOB OBJECTIVE: The Director is responsible for leading the overall Regulatory Affairs strategy and direction for company (premarket, adverse event reporting, recalls, regulatory policy and advocacy for the US and worldwide). Translates strategy into tactics, priorities and resource requirements for execution of plan to assure successful implementation and ultimate success. A focus on overall team development is imperative for success in this position. Lead the regulatory affairs team in delivering world-class regulatory service to the business by creating and supporting a regulatory compliant culture by providing advice and counsel to business managers.
 
ESSENTIAL DUTIES:

  • Maintain a high degree of knowledge and awareness of the external environment and work with external associations & global regulatory bodies to remain current. Proactively adapt regulatory strategies and influence change within areas of responsibility.
  • Identify regulatory trends in the region and their implications for company, taking into consideration the impact on business decisions.
  • Ensure compliance with applicable regulations (US FDA QSRs, Europe IVDD/IVDR, Health Canada regulations, MDSAP requirements, ISO 13485, etc.).
  • Analyze and communicate proposed, new or changing requirements, lead teams to develop strategies to implement and sustain compliance requirements. Oversee all programs and processes to meet business objectives and ensure compliance with regulatory requirements.
  • Evaluate performance metrics to identify program opportunities, recommend and initiate improvements in procedures or oversight.
  • Mentor, coach and teach direct and indirect reports on activities within areas of responsibility. Effectively manage the recruitment, development, training and performance management of direct reports.
  • Educate, train, advise and coach company professionals among cross functional teams to ensure compliance with RA requirements.
  • Work collaboratively with other departments, managers and staff throughout all branches to ensure a consistent approach to regulations is adopted throughout the business.
  • Lead and support continuous improvement activities regarding areas of responsibility.
  • Understands and complies with ethical, legal and regulatory requirements applicable to the business.
  • Represent company in professional or technical product support roles as local, national, and international trade shows, exhibitions, conferences, and awards as directed.
  • Contact customers directly about quality issues or questions as directed.
  • Organize and implement training programs in areas of Regulatory Affairs.
  • May lead and/or direct other areas related to Quality Systems, e.g. CAPA, Nonconforming, Internal Audit as needed.

 
QUALIFICATIONS:

  • Bachelor’s Degree in a science or engineering related field or equivalent work experience.
  • 10+ years’ experience in the medical device industry (prefer IVD) with knowledge and experience applying global device laws & regulations for product registration, adverse event reporting, & recalls.
  • Class I and II medical device experience.
  • Regulatory Affairs Certified (RAC) preferred.
  • At least 6 years leadership experience, including training and coaching of team members.
  • Demonstrated ability to lead cross-functional, cross-business teams.
  • Advanced knowledge and experience managing regulatory issues and interfacing with local and   international regulatory bodies, such as FDA, European competent authorities and notified bodies, Health Canada, SFDA, KFDA, etc. 
  • Advanced ability to prioritize, plan, delegate and evaluate deliverables to established strategic goals. 
  • Demonstrated experience operating in a highly regulated environment.
  • Excellent verbal and written communication and presentation skills with the ability to influence and make recommendations at all levels of the company.