Regulatory Affairs Sr Specialist- Medical device software focus at TerumoBCT, Inc.
Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Lakewood, Colorado
JOB TITLE: Senior Regulatory Affairs Specialist-Medical Device Software focus
Working under broad supervision, assists in fulfilling Regulatory compliance requirements for more than one product/project by applying a thorough understanding of Regulatory standards to one or more areas of expertise such as regulations for medical devices, pharmaceuticals or biologics.
* This position will work with software medical device products including both stand-alone software (SaMD) and embedded software (SiMD).
* Expert in regulations in order to author entire Regulatory dossiers and identify and suggest potential strategies that can be used to address the gaps
* Identifies and defines contents for Regulatory submissions/dossiers. Leads the assembly and creation of these documents for their timely submission to Regulatory authorities.
* Provides Regulatory support to life cycle project teams at any point in the development process
* Interacts with and/or directs others in interacting with Regulatory and Certification authorities
* Identifies the need for, prepares, and conducts Regulatory related training for the business
* Represents functional area within specific business area to provide guidance and recommendations for issues that may arise. May require approvals from management.
* Assumes major responsibility for one or more major Regulatory Affairs areas based on past experience and a broad base of knowledge and understanding of regulatory requirements Identify problems and significantly improve, change or adapt existing methods and techniques drawing from personal experiences and feedback
* Reviews device labeling , advertising materials and product manufacturing changes for compliance with global regulations; analyses and recommends appropriate changes
* Advises business management of regulatory and certification issues in a pro-active manner
* Exercises considerable judgment in determining approach and then researches, prepares, and submits required regulatory documents including those in response to documents issued by regulatory authorities. Responsibility includes both preparation of these documents in compliance with U.S. and international regulatory authorities and providing guidance to Regulatory staff in the preparation of them.
* Reviews submissions to identify adequacy of sections, overall content of submissions and completeness of submission and consistency of story
* Collaborates with individuals at different levels and develops, or is responsible for the development of either solutions to problems of limited complexity that affect diverse functional areas, or solutions to problems of moderate complexity that may affect a few functional areas
* Executes policies at direction of supervisor and makes recommendations for improvements within the organization
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.
Minimum 7 years experience in Regulatory Affairs
* PMA experience a plus
* In depth knowledge of U.S. and/or international medical device and/or pharmaceuticals and/or biologics regulations and standards
* Demonstrated success in the creation of regulatory submissions such as CE Mark for Class II-III products, IDEs, INDs, 510(k)s, NDAs, ANDAs
* Expert with Regulatory issues within a certain business area, product or geography
* Preferred expertise with medical device regulations such as: 21 CFR 820, ISO 13485, ISO 62304, ISO 60601-1 however expertise knowledge in pharmaceutical or biologic regulations and standards would be considered
* Apply previous regulatory experience to help ensure success of submissions
* Able to apply business insight and have ability to to understand how product approval strategy interacts with business strategy
* Demonstrated ability to collaborate and think outside the box
* Highly qualified regulatory professional with intermediate understanding of and demonstrated experience working with/across multi-functions that are closely related. May be recognized as an expert in regulatory affairs.
* Nimble learning and have ability to actively seek out relevant legislation and competitive information on product lines
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 required (up to once a quarter)
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, 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.
We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers.
Join Terumo BCT as we unlock the potential of blood. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.
As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
Our company has almost $1B in annual revenues and has been voted and recognized as:
* Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
* Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
* One of Colorado s Healthiest Employers by Denver Business Journal (2014 & 2015)
* Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015
Our award-winning culture embraces:
* Leading technology through innovation and R&D
* Wellness programs
* Commitment to quality
* An environment that values, respects and rewards your individual contributions
* A philosophy of intentional growth and responsiveness to world health issues
Click Here to see what our associates have to say about our culture.
Each associate has a positive impact on our future by:
* Connecting to the