Senior Regulatory Affairs Specialist-PMA

at Terumo BCT

Denver, CO

Posted on Oct. 13, 2016

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In order to support a Biomedical Advanced Research and Development Authority (BARDA) grant to initiate a clinical trial using the Mirasol(R) Pathogen Reduction Technology, Terumo BCT is seeking additional support for this Class III device.Working without significant direction, this position provides leadership to the Company in fulfilling regulatory compliance by applying a thorough understanding of regulatory/standards requirements to one or more areas of expertise such as FDA regulations, international medical device regulations, product reimbursement, product liability, and standards.

* 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.
* 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.
* Identifies and defines contents for regulatory submissions/dossiers. Leads the assembly and creation of these documents for their timely submission to regulatory authorities.
* 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.
* Provides regulatory support of clinical trials.

Bachelor's degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Minimum 5 years experience.

* PMA experience required.
* Original PMA experience preferred.


* Knowledge and use of relevant PC software applications and skills to use them effectively.
* Demonstrated ability to communicate effectively both verbally and in writing.
* In depth knowledge of U.S. and/or international medical device regulations and standards.
* Extensive knowledge of and ability to prepare regulatory documentation.
* Proven effective leadership and team skills. Strong interpersonal skills.
* Demonstrated ability to define problems and provide guidance to management in developing and implementing solutions.
* Analytical and creative thinking skills and the ability to solve complex problems.

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.
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.