Lead Regulatory Affairs Consultant

Requisition ID: 32482

At Terumo Blood and Cell Technologies, our 7,000+ global associates take pride in their contributions, knowing that our work profoundly impacts patients' lives worldwide. For Terumo, for Everyone, Everywhere.

We specialize in the development of medical devices and related products designed for the collection, separation, manufacturing, and processing of various blood and cell components. Our innovative technologies and services positively influence patient care every second of every day, and we are dedicated to expanding the number of patients we serve. Advancing healthcare with heart.

With a team comprising some of the industry's brightest minds, an unmatched global presence, comprehensive benefits, and a unique culture, Terumo Blood and Cell Technologies offers an exceptional environment for professional growth and collaboration. Join us and help shape our future. You create your future and ours.

As a Lead Regulatory Affairs Consultant, you will play a crucial role in ensuring adherence to regulatory standards and facilitating the success of our innovative medical products. As a vital contributor, you will devise strategic regulatory approaches, expertly manage submissions, and collaborate across departments to tackle challenges and seize opportunities. Your extensive knowledge of global medical device and pharmaceutical regulations, outstanding communication abilities, and proven success in achieving favorable submissions will make you an invaluable member of our team. Be part of our mission to create a lasting impact on healthcare while enjoying a work environment that fosters growth, creativity, and teamwork.

KEY RESPONSIBILITIES

• Develop regulatory strategies and plans for new or modified products.
• Identify and define content for regulatory submissions/dossiers, influencing testing strategies and report contents. Oversee the assembly of regulatory submissions.
• Draft and prepare U.S. and international submissions for new products, ensuring timely market approval.
• Evaluate product design, manufacturing, packaging, sterilization, and labeling changes for compliance with applicable regulations and prepare submissions as required.
• Maintain and enhance knowledge of domestic and international regulations, guidelines, and standards, applying appropriate implementation strategies.
• Represent regulatory interests on project teams to develop regulatory strategies, reviewing specifications and testing plans/reports with the target market in mind.
• Review product labeling to ensure compliance with applicable U.S. and international regulations.
• Negotiate and interact with Regulatory Agencies and Certification authorities during the development and review process to secure submission approval.
• Identify the need for and conduct regulatory-related training for the business.
• Review advertising and promotional materials for compliance with global regulations; analyze and recommend necessary changes.
• Collaborate with individuals at various levels to develop solutions to problems.
• Make recommendations for organizational improvements.
• Anticipate regulatory challenges and emerging issues throughout the product lifecycle, developing solutions with other regulatory and related teams.
• Participate in the preparation and execution of audits required to maintain market access.
• Identify the need for new or modified regulatory procedures, SOPs, and participate in their development and implementation.
• Interpret regulations and policies, providing guidance to project teams and management to meet requirements.
• Develop and execute strategies for responses to inquiries from FDA, Notified Bodies, and government agencies.
• Provide mentoring, training, and support to other members of the regulatory department.
• Assist in regulatory due diligence for potential and new acquisitions.

MINIMUM QUALIFICATIONS

Education

• Bachelor's degree in physical/biological sciences or engineering preferred, or equivalent education and experience sufficient to perform essential job functions may be considered.
• Previous relevant experience and/or a Master's in Regulatory Affairs may also be considered.

Experience

• Seven (7) years of experience in Regulatory Affairs preferred or a combination of Regulatory and Quality experience in a regulated environment.
• Previous relevant experience and/or a Master's in Regulatory Affairs may also be considered.

Skills

• Excellent written and verbal communication skills.
• Self-motivated with the ability to work independently and take ownership of responsibilities.
• Ability to prioritize and manage multiple projects concurrently.
• Leadership and mentoring skills to guide less experienced regulatory personnel.
• Ability to maintain confidentiality in handling regulatory and clinical documentation.
• Experience authoring a regulatory submission in the U.S., EU, and/or Canada for agency review.
• In-depth knowledge of U.S. and/or international medical device and/or pharmaceuticals and/or biologics regulations and standards.
• Business insight to understand how product approval strategy aligns with business strategy.
• Demonstrated ability to collaborate and think innovatively.
• Able to actively seek out relevant legislation and competitive information on product lines.
• Utilize previous regulatory experience to ensure successful submissions.

Certificates, Licenses, Registrations

Regulatory Affairs Certification (RAC) preferred.

-Or-

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

LOCATION

Remote or Lakewood, Colorado.

TRAVEL

Some travel required (up to once a quarter).

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.

Target Pay Range:$95,900.00 to $119, 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 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, as well as 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.