Senior Regulatory Affairs Specialist

Requisition ID:  31342  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. 

Senior Regulatory Affairs Specialist working independently, is responsible for fulfilling regulatory compliance requirements by applying an understanding of regulatory standards and regulations for medical devices, pharmaceuticals, or biologics.

 

ESSENTIAL DUTIES

• Responsible for developing regulatory strategies and plans for new or modified product.
• Identifies and defines contents for regulatory submissions/dossiers. Influences the testing strategy and test report contents. Supervise the assembly of the regulatory submissions. 
• Write and prepare U.S. and international submissions for new products ensuring timely approval for market release.
• Assess product design, manufacturing, packaging, sterilization, and labeling changes for compliance with applicable regulations and prepare submissions, as required, by geography. 
• Maintain current and grow regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementations strategies. 
• Represents regulatory on project teams to develop regulatory strategies, including reviewing the various specifications and testing plans/reports, keeping in mind defined target market.
• Review product labeling and ensure compliance with applicable US and international regulations.
• Negotiate and interact with and/or directs others in interacting with Regulatory Agencies and Certification authorities, during the development and review process to ensure submission approval.
• Identifies the need for, prepares, and conducts regulatory related training for the business. 
• Reviews advertising and promotional materials for compliance with global regulations; analyses and recommends appropriate changes. 
• Collaborates with individuals at different levels and develops or is responsible for the development of solutions to problems.
• Makes recommendations for improvements within the organization.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Participate in preparation and execution of audit required to enable of maintain market access.
• Identify the need for new or modified regulatory procedures, SOPs, and participates in development and implementation. 
• Interpret the intent of regulations and policies and provide such information to project teams and management. Work with the TBCT organization to meet the requirements.
• Develops and executes strategies for responses to FDA, Notified Body, and government agency questions with team.
• Provide mentoring, training, and support to other members of the regulatory department.
• Assist in regulatory due diligence for potential and new acquisitions.

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

• Bachelor’s degree in physical/biological sciences or engineering preferred, or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Previous relevant experience and/or combined with a Masters in Regulatory Affairs may also be considered.

 

 

Experience

• Seven (7) years' experience in Regulatory Affairs preferred or a mix of Regulatory and Quality experience in a regulated environment. 
• Previous relevant experience and/or combined with a Masters in Regulatory Affairs may also be considered.

 

Skills

• Must have excellent written and verbal communication skills. 
• Must be self-motivated by working independently and having the ability to take ownership of her/his responsibilities.
• Must be able to prioritize and handle several projects concurrently.
• Must be able to provide leadership and mentoring skills and/or supervision to less experienced regulatory personnel.
• Must be able to maintain