Senior Manager, Regulatory Affairs (Submissions)

Terumo BCT, Inc. • Denver, CO

13d • $160,600 - $200,800 • Hybrid

About The Position

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. As the 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.

Requirements

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

Nice To Haves

• Regulatory Affairs Certification (RAC) desired.

Responsibilities

• 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.

Benefits

• Multiple group medical, dental and vision plans
• Robust wellness program
• Life insurance and disability coverages
• Variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance
• 401(k) plan with a matching contribution
• Vacation and sick time programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior