Senior Manager, Regulatory Affairs (Submissions)

Cobioscience; Lakewood (CO); Hybrid; USD 161,000 - 201,000; Full time

Benefits offered by this job

401(k) matching

Vacation and sick time

Wellness program

Job summary

Terumo Blood and Cell Technologies is seeking a Senior Manager of Regulatory Affairs to guide a high-performing team in developing and executing global regulatory submission strategies for innovative medical technologies. You will lead filings with FDA, Health Canada, and EU bodies under EU MDR, drive global market access, and mentor a team of regulatory professionals.

The role collaborates with R&D, Manufacturing, Quality, Operations, and Commercial teams to influence regulatory strategy and

Qualifications

• 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.
• A Masters in Regulatory Affairs or MBA preferred.

Responsibilities

• Develop regulatory submission strategies for global products across FDA, Health Canada, and EU regulatory bodies.
• Lead regulatory inspections and interact with regulatory authorities to ensure compliance and product approvals.
• Mentor regulatory professionals and guide cross-functional teams in regulatory programs.
• Review and approve submissions, arguments, positions, and strategies.

Skills

Regulatory leadership

Project management

Cross-functional collaboration

Regulatory strategy

Quality systems

Regulatory communications

Education

Bachelor’s degree in physical/biological sciences or engineering

Masters in Regulatory Affairs or MBA

Tools

Regulatory submission knowledge

Job description

Requisition ID: 35555

At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

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. Advancing healthcare with heart.

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. Join us and help shape wherever we go next. You create your future and ours.

Senior Manager, Regulatory Affairs, you'll be responsible for guiding a high-performing team that develops and executes global regulatory submission strategies for innovative medical technologies. In this role, you will lead the preparation and submission of critical regulatory filings to agencies such as the FDA, Health Canada, and European regulatory bodies under EU MDR, helping bring new products to market while ensuring ongoing compliance for existing products. Working closely with R&D, Manufacturing, Quality, Operations, and Commercial teams, you will influence regulatory strategy, navigate complex global requirements, lead regulatory inspections, and mentor a team of regulatory professionals. This is a unique opportunity for an experienced regulatory leader to influence product commercialization, drive global market access, and make a meaningful impact on therapies and technologies that improve patient lives around the world.

ESSENTIAL DUTIES

• Develops, or is responsible for the development of, regulatory solutions to problems that may affect diverse functional areas of the business or company or unusual complexity in the function to improve overall effectiveness of regulatory affairs and its intersection with other departments.
• Analyze changing business, internal customer and staffing needs and develops and directs implementation of plans to achieve cross-functional short and long term business goals that support overall business and corporate objectives.

• Interprets, executes, and recommends modifications to operating policies at business level within and outside area of responsibility. Will establish operating policies within specific business operating area and recommend policies that impact other areas.
• Bring together multiple concepts across job areas to define a new direction or a significant advancements to regulatory processes, prioritizing recommendations on how to achieve regulatory timelines and/or regulatory compliance.
• Represent multiple business areas or geographies as the primary contact. Interacts with business area management teams and/or regulatory authorities. Recommends and coordinates specific actions with senior management team.
• Oversees preparation and submission of regulatory documents, acts as internal and external consultant on regulatory issues and leads regulatory and certification inspections.
• Works with industry groups, elected officials, and governmental personnel to advance company interests.
• Hands-on development of regulatory submissions such as CE Mark for Class II-III products, IDE’s, IND’s, 510(k)’s, NDA’s, ANDA’s.
• Leads regulatory inspections and interacts with regulatory bodies on compliance issues.
• Monitors, reports, and comments on changes in U.S. and international regulatory policies and issues through monitoring of new regulations, guidelines, policies, and standards; trade papers, and journals; membership and participation in professional organizations; and attendance of regulatory seminars and training programs.
• Participates, promotes and leads subordinate participation on cross-functional and/or inter organizational teams.
• Responsible for reviewing and approving submissions, arguments, positions, and strategies.
• Involved in creating/ proposing product approval strategy.

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. A Masters in Regulatory Affairs or MBA preferred.

Experience

Minimum 10 years experience in Regulatory Affairs and 3 years direct regulatory management experience, including:

• Leading regulatory inspections and interacting with regulatory bodies on compliance issues.
• Developing quality and productivity goals and measures.
• Commercial partnership experience – understanding how to balance regulatory compliance with business needs.
• Strategic regulatory positioning to ensure best probability of success in a timely manner.
• Actively seeking out relevant legislation and competitive information on competitors and been involved in ideas to influence legislation.

Skills

• Recognized as an expert within the company with diverse and varied understanding and experience working with multiple functions that are unrelated.
• Working knowledge of medical and therapeutic medical devices or pharmaceuticals or biologics.
• Able to manage ambiguity and have ability to fill gaps with alternative data.
• Expert across multiple business areas, able to manage complex projects, and are able to get results within a matrix organization.
• Has resourcefulness and ability to drive for results to work on new, high challenge products, new platforms or projects across business areas.
• Recognized, internally and externally, as having exceptional expertise and vision in Regulatory and the intersection with other departments.
• Broad knowledge of management of people, complex projects, and regulatory affairs.
• Demonstrated effective leadership, managerial, and strategic planning skills.
• Possess financial acumen and strategic mindset.
• Ability to develop talent and drive engagement.
• Demonstrated project management skills.
• Extensive knowledge of U.S. and international medical device regulations including quality systems regulation international standards.
• Exceptional understanding of quality management techniques and theories.
• Demonstrated ability to effectively work with regulatory agencies to advance company interests.
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Demonstrated ability to communicate effectively both verbally and in writing.

-Or-

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

Certificates, Licenses, Registrations

Regulatory Affairs Certification (RAC) desired.

LOCATION

Lakewood, Colorado (hybrid) - Open to candidates willing to relocate to the area.

TRAVEL

Some travel may be required (5-10%).

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:$160,600.00to$200,800.00 -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:20.0%

We anticipate this requisition will be open for a minimum of five days, from October 6, 2026.

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 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue.
• We employ nearly 8,000 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 $2.4 million USD since 2025.

We are proud to be an Equal Opportunity Aff…? actually complete text: We are proud to be an Equal Opportunity ... (full statement)

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.