Regulatory Affairs Specialist

• Supports all business segment initiatives as

Complies withU.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. 

Maintainspositive and cooperative communications and collaboration with all levels of employees

Required Qualifications 

• Bachelor's Degree (± 16 years), Technical discipline preferred OR an equivalent combination of education and work experience

• No Experience, some experience with medical device industry preferred.

• Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability toleverageand/or engage others in accomplishing projects. Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes, and meets deadlinesin a timely manner. Strong organizational and follow-up skills, as well as attention to detail.

Preferred Qualifications 

• Master’s Degree (± 18 years), In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred

• 2 years, In a regulated industry (e.g., medical products, nutritionals). Regulatoryarea ispreferred but may consider quality assurance, research and development/support, scientific affairs, operations, or relatedarea.

• Regulatory Knowledge of:Regulatory history, guidelines, policies, standards, practices,requirementsand precedents.Regulatory agency structure,processesand key personnel.Principles and requirements of applicable product laws.Submission/registrationtypes and requirements.GxPs (GCPs, GLPs, GMPs).Principles and requirementsofpromotion,advertisingand labeling. Note: This knowledge may be developed through tenure in this position.Communication Skills or Ability to:Communicate effectively verbally and in writing.Learn to write and edit technical documents.Work with cross-functional teams.Work with people from various disciplines and cultures.Cognitive Skills or Ability to:Pay strong attention to detail.Handle detailed tasks and prioritize them.Meetdeadlines.Think analytically and critically.Review and analyze documentation.Research andlocateinformation on regulatory requirements and products.Exercise judgment within defined procedures and practices to determine appropriate action.Has general knowledge of technical alternatives andgainan understanding of their impact on the systems environment.Apply business ethical standards.