Principal, Regulatory Affairs Specialist

Requisition ID : 32476

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.

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.

We are actively seeking a highly skilled Principal Regulatory Affairs Specialist to lead our FDA, Health Canada, and / or EU MDR submissions process.

As a key player in our organization, you will leverage your extensive expertise to navigate the regulatory landscape, ensuring successful approvals for our innovative healthcare solutions.

Your responsibilities will include developing and executing regulatory strategies, collaborating with cross-functional teams, and ensuring compliance with global regulations.

If you are a regulatory champion looking for a challenging and rewarding opportunity, apply now to be at the forefront of advancing healthcare technologies.

ESSENTIAL DUTIES

• Recognized as an expert within the company with diverse and varied understanding and experience working with multiple functions that are unrelated.
• Responsible for managing complete lifecycle of multiple complex products and / or projects simulatenoulsy.
• Acts a company representative, creating and maintain positive relationships with regulatory agencies throughout the development process (Pre-Submissions, Submissions, Post Market).
• Develops, or is responsible for the development of, solutions to problems of high complexity that may affect diverse functional areas of the business or company or unusual complexity in the function.
• Identify problems and significantly improve, change or adapt existing methods and techniques , may be involved in creating / proposing strategy.
• Maintains proficiency in worldwide regulatory requirements; monitors changes in the regulatory landscape and is responsible to communicate these changes and the impact to the organization.
• Represent specific business areas or geographies as the primary contact; interacts with business area management teams and / or regulatory authorities.
• May review device labeling , advertising materials and product manufacturing changes for compliance with global regulations;

analyzes and recommends appropriate changesRepresent departmental function, and collaborates with individual at different levels in solving problems that are complex in nature.

• Can interpret and recommend modifications to operating policies within the function, which may influence overall objectives and long-range goals.
• Reviews staff submissions to identify adequacy of sections, overall content of submissions and completeness of submission and consistency of story.
• Responsible for authoring entire submissions / dossiers.
• Provides technical guidance and regulatory training / mentoring to other Regulatory Associates and / or cross functional teams.
• Acts a leader who embodies regulatory expertise as well as business acumen with a positive corporate mindset.

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.

Such as a Masters in Regulatory Affairs or MBA.

Experience

Minimum 10 years experience in Regulatory Affairs.

• Clinical or statistical experience desired.
• PMA experience a plus.

Skills

• Posses expert knowledge related to Regulatory issues involving multiple product lines, or geographies, or specific business processes and procedures.
• Demonstrated success in the management of regulatory submissionssuch as CE Mark for Class II-III products, IDE's, IND's, 510(k)'s, NDA's, ANDA's.
• Advanced expertise with medical device regulations such as : CFR 820, ISO 13485, ISO 62304, ISO 60601-1 however expertise knowledge in pharmaceutical or biologic regulations and standards would be consideredAble to apply business insight and have ability to to understand how product approval strategy interacts with business strategy.
• Ability to comprehend principles of engineering, software development, chemistry, and science in order to work closely with a variety of associates to better understand the products and support the product lifecycle.
• Nimble learning and have ability to actively seek out relevant legislation and competitive information on product lines.
• Has resourcefulness and ability to drive for results to work on new, high challenge products, new platforms or projects across business areas.
• 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.
• Experience in an environment where skills in negotiation, listening, persuasion, collaboration, compromise and analytic based judgement is used daily.
• 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.

Certificates, Licenses, Registrations

Regulatory Affairs Certification (RAC) desired.

LOCATION

Remote or Lakewood, Colorado.

TRAVEL

Some travel required (up to 5%)

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 : $121,200.00to$151,600.00 -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.