Our client is an established and growing global company within the Medical Device industry with a growing Wound Care and OTC division including impressive patented technology. Their growth in the US has created the need for additional regulatory leadership; RA or Senior RA Manager. This is an opportunity for an experienced SRAS, PRAS, RA Project Manager, or RA Manager to take the next step in their career by moving into an RA Manager or Senior RA Manager role with the opportunity to grow.
Our client is looking for a problem-solver, a person interested in growth and a seat at the table for corporate initiatives and strategy in the US.
The Right Talent:
BS in engineering or Science/MS Preferred
5+ years of Regulatory Affairs experience in the medical device or Biotech industries
Experience with the FDA, governing bodies and understanding of regulatory submissions
Experience with labeling, marketing collateral & risk management
Experience with clinical research, CER and Protocol Design
Experience substantiating claims for research a plus
Experience with KOL Development a plus
Must have strong emotional maturity & problem-solving ability
Please no Visa applications or transfers
Relocation assistance possible
Opportunity to work remotely during the week with 1-2 days in the office