The Manager of Regulatory Affairs will support life science project teams. This position is not connected with team management. -Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing strategies, policies and procedures that ensure regulatory requirements for life science products.
-Work with International Trade Compliance, Product Development and Global EH & S to identify and analyze new regulations and standards and implement requirements in internal procedures.
-Ensure on-going compliance to applicable instrument, software, and/or reagent standards, directives and regulations. (e.g., ISO, CSA, TUV, OSHA, etc.).
-Prepare European Union CE Technical Files for life science instruments.
-Review product labeling and promotional literature for regulatory compliance in the least burdensome manner. -Interface with CSA Group and other certification bodies for inquiries and issues.
-Work closely with QA and instrument platform teams to coordinate quarterly standards and regulations reviews. -Develop regulatory process SOPs.
-Minimum Bachelor’s Degree in a scientific discipline.
-Experience in the medical device, pharmaceutical or biologics industry.
-At least 2 years of experience in Regulatory Affairs
-Fluency in English language required.
We offer: • Possibility to develop in an international company • Training and development programs • Private medical care • Group Life Insurance • Multisport card • Flexible benefits platform • Language classes • Pension Scheme (PPE) after 12 months • Childcare subsidy • Happy Monday :) • Friendly atmosphere • Casual dress code • Attractive location