Regulatory Affairs Tender & Intelligence Sr Manager

AubonnePermanentChemistry, Pharma, Biotech2019-03-29Bachelor / University of Applied Sciences
Spring Life Sciences is looking for his client a:

Regulatory Affairs Tender & Intelligence Sr Manager

Your challenges

  • Regulatory Surveillance, advocacy with government bodies and manufacturer associations across Europe, implementation of new regulation, tender management
  • Develop & implement regulatory intelligence and regulatory surveillance strategies to ensure full awareness of regulation affecting the company operations
  • Advise and influence operational decisions accordingly
  • Develop long range regulatory, quality or compliance projects together with the corporate headquarters to ensure implementation of applicable regulation and guidelines
  • Company representative at the European trade associations to ensure that compliance interpretations are obtained, understood and appropriately communicated and documented in internal procedures, carry out our advocacy activities to defend and promote company policy objectives
  • Partner with domestic and international teams to respond to public tenders requirements
  • Implements and supports Quality Management System activities such as CAPA, documentation, training, management review, audit
  • Other regulatory projects may be assigned as necessary
  • Travel: up to 30%

Your skills

  • At least 10+ years' experience in medical device industry operating according to US or EU regulation including at least 3 years in regulatory affairs and quality assurance
  • A Bachelor degree, Engineering or Master's degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
  • In-depth knowledge of EU MDD 93/42/EEC, EU MDR 2017/745/EU, US FDA CFR 21, ISO 13485
  • Significant experience (typically >3 years) representing the company to external regulatory agencies Strong interpersonal skills with ability to lead projects autonomously and to collaborate effectively with various scientific and business representatives in international team environment
  • Ability to foresee regulatory challenges and develop critical concepts and methodologies to overcome these
  • Team management experience of small team size associated with goals objectives definition / people development
  • Demonstrated autonomy, organizational and planning skills, including action oriented and can-do attitude, focused urgency and driving for results
  • Excellent verbal and written communication and presentation skills, ability to distill complexity and provide clear and actionable direction
  • Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
  • Language: Fluent English and French or German
  • Regulatory Affairs Certification (RAC) is a plus
  • Environmental regulation knowledge (REACH, ROHS, WEEE)

Your contact

Are you interested? Please apply directly online.

The reference of this job ad is JN -032019-295420