Manager, Regulatory Affairs
Requisition ID: 26542
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.
JOB TITLE: Regulatory Affairs Manager
Performs regulatory activities and is responsible to manage product registrations and submissions for product lines and / or geographical areas. Supports activities related tothe launch of new products, maintenance of existing products and maintains regulatory compliance and regulatory systems for the company.
- Develops, or is responsible for the development of, regulatory solutions to problems of moderate to intermediate complexity that may affect diverse functional areas of the business or company or unusual complexity in the function
- Provides technical guidance and regulatory training/mentoring to other Regulatory Associates and/or cross functional teams
- Create new methods, techniques and/or processes across job areas or functions exerting some influence on the overall objectives and long-range goals
- Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives
- Represent specific business areas or geographies as the primary contact, interacting and creatingan ongoing, proactive relationship and collaboration with internal scientific, marketing, and engineering colleagues and/or regulatory authorities. Coordinate activities with senior management team.
- Responsible for overseeing regulatory compliance, development and timely national and international regulatory submissions, ensuring that all regulatory activities are conducted with the highest integrity and in an ethical manner
- Reviews staff submissions to identify adequacy of sections, completeness and consistency of story and overall content of submissions, may be responsible for authoring submissions when needed
- Represent departmental function, acting as primary interface with regulators, presenting strategies and negotiating solutions, and may lead and coordinate intra- and inter-company projects
- Interprets, executes, and recommends modifications to operating policies at business level. Will establish operating policies within specific business operating area and recommend policies that impact other areas.
- Shares experience with most stages of product life cycle and concentrates on new product development and post-market applications of existing products
- Communicates regulatory strategy effectively to all departments, senior management, regulators, and regulatory agencies to achieve timelines
- Ensures that all outside official communications comply with the appropriate regulations and internally approved regulatory and marketing claims
- Acts as an effective regulatory consultant to management and other functions
- Acts a leader who embodies regulatory expertise as well as business acumen with a positive corporate mindset
MINIMUM QUALIFICATION 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. Such as a Masters in Regulatory Affiars or MBA.
Minimum 8 years experience in Regulatory Affairs and 1 year of direct or indirect management experience preferred
- PMA experience a plus
- Direct experience in gaining FDA or Notified Body approvals for devices or drugs or biologics
- Experience in an environment where skills in negotiation, listening, persuasion, collaboration, compromise and analytic based judgement is used daily
- Demonstrated success in the management of regulatory submissions such as as CE Mark for Class II-III products, IDE’s, IND’s, 510(k)’s, NDA’s, ANDA’s
- Knowledge of technical aspects of regulatory profession, combined with scientific understanding and project management skills
- Understands how product approval strategies interact with business strategies. Identifies regulatory and clinical challenges and ability to resolve them through collaboration
- Recognized as an emerging authority within the business or function with broad understanding of and experience working with multiple functions that are unrelated
- Able to manage ambiguity and have ability to fill gaps with alternative data
- Expert with Regulatory issues involving multiple product lines, or geographies, or specific business processes and procedures
- Possess business insight and have ability to understand how product approval strategy interacts with business strategy, may involve in creating/ proposing such strategy
- Nimble learning and able to actively seek out relevant legislation and competitive information on product lines
- Must be results oriented and decisive. Failure to obtain results or arrive at approproiate decisions in a timely fashion could impact compliance risk or cause delays in planned product launch.
- Demonstrated analytical and creative thinking skills and the ability to solve complex problems
- Able to mentor and develop talent of direct reports
- Ability to interact with diplomacy and tact while maintaining appropriate assertiveness
- Willingness to take ownership and accept responsibility, ensuring accountability for actions and decisions
- Must be detail oriented, well organized and able to work both independently and in teams
- Knowledge and use of relevant PC software applications and skills to use them effectively
- Demonstrated ability to communicate effectively both verbally and in writing
Certificates, Licenses, Registrations
Regulatory Affairs Certification (RAC) desired.
An equivalent competency level acquired through a variation of these qualifications may be considered.
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 may be required (5-10%)
- 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.
Learn more here
Job posted: 2020-11-19