Regulatory Affairs Specialist (Temporary Associate)

at Terumo BCT

Denver, CO

Posted on Oct. 19, 2016

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Working without significant direction, assists 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.
ESSENTIAL DUTIES

* Using a broad base of knowledge and understanding of regulatory requirements, assumes major responsibility for one or more major regulatory affairs areas.
* Identifies and defines contents for regulatory submissions/dossiers. Leads the assembly and creation of these documents for their timely submission to regulatory authorities.
* Responsible for overall compliance with regulatory requirements that apply to the product development cycle. Makes and prioritizes recommendations on how to achieve compliance.
* Identifies areas where the business can effect improvements and establishes operating policies with direction.
* Works with manufacturing, engineering, and other functional groups on regulatory compliance issues.
* Interprets, executes, and recommends modifications to operating policies where appropriate.
* Provides accurate and timely turnaround time on complaints, returned goods, releases, trend reports, and other activities. Maintains related reports that are accurate and concise.
* Updates and maintains all product release indices.
* Supports non-US based facilities in meeting Quality System and regulatory requirements.
* Maintains regulatory required records per record retention requirements. And keeps certification documents current.

MINIMUM QUALIFICATION REQUIREMENTS
EDUCATION
Bachelor's degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
EXPERIENCE
Minimum 4 years experience.

SKILLS

* Knowledge and use of relevant PC software applications and skills to use them effectively.
* Demonstrated ability to communicate effectively both verbally and in writing.
* Must be highly skilled in timely and accurate decisions.
* In depth knowledge of U.S. and/or international medical device regulations and standards.
* Working knowledge of and ability to prepare regulatory documentation.
* Demonstrated analytical and creative thinking skills and the ability to solve complex problems.

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.
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.