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15 days old

Senior Regulatory Affairs Specialist

Kelly Services
O'Fallon, MO 63366
**Senior Regulatory Affairs Specialist EU MDR**


Kelly Services has provided outstanding employment opportunities to the most talented professionals in the marketplace. Today, we are proud to offer an excellent contract opportunity for a with our client, a leader Senior **Regulatory Affairs Specialist** in a leading medical device company, located in OFallon, MO.


REMOTE option!


14 month assignment!


Responsible for providing Regulatory Affairs support under direct supervision for regulatory authorizations to market medical device products in the EU. This position requires the incumbent to work under the direct supervision of senior regulatory professionals in the collection and collation of materials required for EU MDR submissions. May provide preliminary review of product technical information, certification documentation, master file documents. Position may support facility inspections and participate in other regulatory support activities as required.The position acts as a liaison between product development teams and global regulatory agencies to communicate technical product design for product approvals through participation in preparation of product submissions and license renewals, and daily maintenance of business issues.


+ EU MDR submissions based on input from RA Managers and Regional Regulatory groups.

+ Research engineering standards and medical device regulations.

+ Support RA Managers in interactions with Notified Body and EU government agencies with product approval issues.

+ Support/participate in EU MDR project reviews.

+ Participate as required in audits facilities.

+ Assist in providing applicable regulatory information to support import/export applications.

+ Ensure records related to product approvals and licenses are accurate and maintained according to departmental requirements.

+ Administrative functions as needed

+ The core activities are generating regulatory submissions and the life cycle maintenance of those submissions for domestic and international product registrations.


**Qualifications:**


BA/BS degree in a technical or scientific discipline such as biology, chemistry, physiology, engineering, medical or law or related regulatory affairs experience with medical devices or pharmaceuticals


Minimum 5 years' experience in Regulatory Affairs for Medical Devices with familiarity in preparing submissions for US Class II/Class III medical devices and/or EU class Ila/Class Ilb medical devices. Knowledge of medical device or drug GMP's required.


+ Experience preparing EU MDD/MDR medical device registrations is required.

+ Knowledge of U.S. FDA medical device regulations and guidance documents.

+ Must have excellent communication, organization, time management and writing skills.

+ Strong interpersonal skills required in areas of verbal and written communications, service to internal customers, and professionalism.

+ Strong questioning and problem-solving skills.

+ Must be self-motivated by working independently and having the ability to take ownership of his/her responsibilities.

+ Must have command of English language.

+ Computer literate with general office software and internet use.

+ Ability to read, analyze and interpret governmental regulations, general business periodicals, professional journals and technical procedures.

+ Ability to write routine reports and business correspondence.


**Important information** : This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-10-06 Expires: 2021-11-18

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Senior Regulatory Affairs Specialist

Kelly Services
O'Fallon, MO 63366

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