Is This The Role For You?
We hire smart people with big hearts. People who have a passion for their work and who strive every day to help others. Our work requires bold and innovative leaders; people who bring strong values and ethics to their role.
If you're ready for a career that allows you to grow and develop into the professional you want to be - today and in the future….CryoLife is the place for you.Position Overview />
The Senior Regulatory Affairs (RA) Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions, and obtaining and maintaining approval for products to markets worldwide. Additionally, the Sr. RA Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. The Sr. RA Specialist will work independently, manage their own regulatory projects, and provide guidance and support to junior staff.Responsibilities />
- Define the regulatory strategies and submission activities (510(k), IDE, PMA, EU/CE Technical Documentation Files, Canadian License, international registrations, including amendments, supplements, renewals, annual reports and responses to requests for additional information) for complex new product development activities and product maintenance for existing approved products.
- Team with global partners and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products.
- Work with cross-functional teams and subject matter experts to maintain regulatory compliance and address questions from regulatory agencies.
- Review significant product submissions with project stakeholders and negotiate submission issues with agency personnel. Ensure timely submission approvals and product market release.
- Provide support to currently marketed products, including review of labeling, promotional material, product changes and documentation for changes.
- Support regulatory compliance activities, including facility site registrations, audits, etc., as needed.
- Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
- Provide feedback and on-going support to product development teams for regulatory issues and questions.
- Ensure personal understanding of all quality policy/system items that are personally applicable.
- Follow all work/quality procedures to ensure quality system compliance and high-quality work.
- Support general quality system programs (CAPAs, NCRs, internal/external audits, PMS, Risk Management, etc.)
- Maintain and update regulatory processes and SOPs.
- Provide support and guidance to junior team members.
- Other duties as assigned.
- Bachelor's degree and a minimum of 4 years of regulatory experience or an advanced degree with a minimum of 2 years of regulatory experience
- Experience with FDA Class II or III devices or experience with EU Class IIb or III devices
- Experience working with cross-functional teams
- Ability to comprehend principles of engineering, physiology, and medical device use
- Ability to effectively manage and prioritize numerous projects and responsibilities
- Strong analytical, technical writing, verbal/written communication, organizational, and time management skills
- Must be flexible, able to adapt easily, and willing to take initiative and lead regulatory projects
- Experience with Health Canada Class 3 or 4 devices, international submissions, cardiovascular devices or human tissue preferred
- Must be legally authorized to work in the United States
- Must be willing to submit to a pre-employment background check and drug screen
- Must be at least 18 years of age
Who We Are.
CryoLife is one of the world's leading contemporary medical device companies whose technology and products bring restoration and hope to people all around the world. With a variety of innovative products and technologies available, including preserved human cardiac and vascular tissues, surgical adhesives and sealants, and mechanical heart valves, our mission is to restore the health of patients by delivering innovative technologies of unsurpassed quality. Since our inception in 1984, it is estimated that our products and tissues have been implanted in over 1 million patients worldwide. Headquartered in Kennesaw, Georgia, CryoLife employs over one thousand people from various education and experiential backgrounds across the United States and internationally.
CryoLife is an Equal Opportunity/Affirmative Action employer.
CryoLife provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
CryoLife is committed to providing reasonable accommodations both in the application and interview process, consistent with legal requirements. If you need a reasonable accommodation while seeking employment, please email or call . A Human Resources representative will return your call. Messages or emails for any reason other than accommodation requests will not be returned.