Regulatory Affairs, Senior Specialist (US Submissions)

Requisition ID: 30152

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.

As a Regulatory Affairs Specialist you play a pivotal role in ensuring regulatory compliance and driving the success of our innovative medical products. As a key contributor, you will develop strategic regulatory plans, expertly navigate submissions, and collaborate cross-functionally to address challenges and seize opportunities. Your in-depth knowledge of global medical device and pharmaceutical regulations, exceptional communication skills, and proven track record in achieving successful submissions will make you an invaluable asset. Be a part of our mission to make a lasting impact on healthcare while enjoying a work environment that encourages growth, creativity, and collaboration.

ESSENTIAL DUTIES

• Responsible for developing regulatory strategies and plans for new or modified products.
• Identifies and defines contents for regulatory submissions/dossiers. Influenes the testing strategy and test report contents. Supervises the assembly of the regulatory submissions.
• Write and prepare submissions to regulatory agencies.
• Develop and execute strategies for responses to FDA, Notified Body, and government agency questions with cross-functional team.
• 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.
• Represent regulatory on project teams to develp regulatory strategies, including reviewing teh various specification and testing plans/reports, keeping in mind defined target market.
• 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.
• 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; analysis and recommends appropriate changes.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Identify the need for new or modified regulatory procedures, SOPs, and participates in development and implementation.
• 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.
• Provide mentoring, training, and support to other members of the regulatory department.
• Other tasks, as required.

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.
• Minimum 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, experience with coordinating large/complex projects is a plus.
• Must be able to provide leadership and mentoring skills and/or supervision to less experienced regulatory personnel.
• Must be able to maintain confidentiality in dealing with regulatory and clinical documentation.
• Must have authored a regulatory submission in the US, EU and/or Canada that was submitted for regulated agency review.
• Must have in-depth working knowledge of U.S. and/or international medical device and/or pharmaceuticals and/or biologics regulations and standards and the ability to apply knowledge to submissions reviewed by a regulated agency.
• Able to apply business insight and have ability to understand how product approval strategy interacts with business strategy.
• Demonstrated ability to collaborate and think innovatively (outside the box).
• Nimble learning and have ability to actively seek out relevant legislation and competitive information on product lines.
• Apply previous regulatory experience to help ensure success of submissions.

Certificates, Licenses, Registrations

Regulatory Affairs Certification (RAC) preferred.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

Typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Additional Physical Requirements

Some travel required (up to once a quarter).

Target Pay Range:$90,700.00to$113,300.00 -Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data

Target Bonus on Base:10.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
• We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
  
  
  
  • Respect - Appreciative of others
  • Integrity - Guided by our mission
  • Care - Empathetic to patients
  • Quality - Committed to excellence
  • Creativity - Striving for innovation
  
  
  
  
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment.Our Colorado campus locations are tobacco-free workplaces and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.Absent accommodation permitted by applicable law, as a condition of employment with Terumo Blood and Cell Technologiesin the United States you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.