Sr Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences

Responsibilities:

• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• For Office Roles: While performing this job's duties, the employee is regularly required to be independently mobile.

• The employee is also required to interact with a computer and communicate with peers and co-workers.

• Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Requirements:

• Bachelor's degree with 3 years of regulatory affairs experience

• OR an advanced degree with 2 years of regulatory affairs experience

• 3+ years of experience in medical device regulatory affairs with roles showing increasing responsibility.

• US and global regulatory affairs knowledge and experience.

• Microsoft Word, Excel and Adobe software skills.

• Experience working with cross-functional teams.

• Experience working with technical documentation/Global Submission Summary documentation.

• Effective verbal and written communication skills both internally and externally.

• Experience with solving problems and concerns.

• Experience with project management and adherence to time schedules.

• Work well under pressure in a dynamic environment.

• Highly organized, detail-oriented, and efficient.

• Team player who seeks to help and learn from colleagues seeing the department success as.

• Proactively seeks to develop and become well-versed within the regulatory landscape.

• RAPS Regulatory Affairs Certification (RAC).