Careers

Job Brief

Experienced professional which integrates basic regulatory knowledge throughout product lifecycle with aspects of effective management and strategy.  This position supports the RA function by assisting the coordination and preparation of global regulatory premarket submissions.

Essential Job Functions

• Support registration process in the EMEA markets including Europe/MDR and APAC regions.

• Participate on multidisciplinary teams and communicate regulatory requirements effectively.

• Ensure alignment and compliance with local and regional registration requirements worldwide.

• Conduct appropriate research to develop strong regulatory strategies for new products.

• Determine issues which may create regulatory obstacles and investigate solutions to address these issues.

• Oversee the organization and preparation of regulatory submissions and all applicable documentation.

• Evaluate regulatory impact of proposed design and manufacturing changes (ECO process).

• Adhere to Code of Ethics for Regulatory professionals.

• Assist in departmental SOP development and implementation.

• Maintain regulatory files as required by departmental procedure.

• Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders.

• Assist with environmental regulations and standards (i.e. RoHS, etc.)

• All other duties as requested by his/her manager.

Knowledge/Educational Requirements

• Bachelor’s degree preferably in a scientific discipline such as Science, Engineering or BioMedical.

• Masters in Regulatory Affairs or Regulatory Affairs Certification (RAC) is a plus.

• 5 plus years of Class II or Class III global medical device regulatory experience is required.

• Strong regulatory writing skills

• Ability to apply business and Regulatory Affairs ethical standards

Excellent analytical and critical thinking skills