1+ months

Senior Regulatory Affairs Specialist (Medical Device)

Kelly Services
Hatfield, PA 19440
**Senior Regulatory Affairs Specialist**

**Medical Devices**

Hatfield, PA

Direct Hire/Salaried

The Senior Regulatory Affairs Specialist will be responsible for the appropriate licensing and legal compliance required for the distribution of medical products domestically, regionally, and globally, in conjunction with marketing forecasts and plans. This role will require the combined knowledge of scientific, legal and business issues, to enable products to be distributed by DITC in accordance with required regulations. The incumbent will advise on and co-ordinate the approval and registration of DITC products as required. The Senior Regulatory Affairs Specialist will act as the liaison linking DITC and its products with regulatory authorities, including the US Food and Drug Administration (FDA), local and state agencies and regulatory authorities worldwide.


+ Work with product development teams to ensure that the company's products comply with the US Food and Drug Administration (FDA), local and state agencies and international regulations for areas the products are intended for distribution.

+ Maintain current knowledge regarding applicable international legislation, guidelines, and standards.

+ Maintain current knowledge of the company's range of products.

+ Collect, organize and maintain a wide range of information pertaining to the safety, efficacy, and/or substantial equivalence of the companys products.

+ Develop and write clear justifications and explanations for new product licenses and license renewals.

+ Work with specialized computer software and resources.

+ Review, advise and recommend changes to product labels, work instructions, and user manuals to ensure ease of use and regulatory compliance

+ Interpret design, test, and validation data and work within the organization to resolve any issues needed for successful registration/reregistration.

+ Advise and support engineers and management on regulatory requirements.

+ Work with project teams and colleagues involved with the development of new and changed products to advise them on regulatory/licensing.

+ Develop and maintain excellent working relationships with regional Regulatory Affairs teams, dealers and distributors throughout the world to ensure their assistance and cooperation on regulatory issues including licensing, registrations, complaint issues/reports, new/emerging regulatory requirements, recalls, withdrawals, and notifications.

+ Help maintain the companys quality system to reflect current requirements and state-of-the-art.

+ Assist/support/participate, as appropriate, with regulatory inspections and third-party audits.

+ Review Companys practices, provide advice and propose changes/improvements to systems and processes.

+ Liaise with regulatory authorities on issues relating to submissions, approvals or clearance of the companys medical devices, as needed.

+ Maintain systems and ensure timely submission of licenses and applications to authorities, adhering to strict deadlines.

+ Assist Engineering and/or other functional groups in prototype development, evaluation and documentation.

+ Other duties as assigned.


+ Bachelors of Science degree.

+ 5+ years of related experience in the Medical Device industry.

+ Ability to analyze and assimilate data including engineering drawings, specifications, labeling, statutory and regulatory requirements.

+ Proficient use of computers, MS-Office (Word, PowerPoint, and Excel knowledge required).

+ Must be able to work in a standard office environment.

+ Some travel may be required.


+ Knowledge of EU MDD and MDR rules and regulations.

+ Experience with imaging systems and software.

+ Superior written, verbal, interpersonal communications.

+ Self-motivated and able to work with minimum supervision.

**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. (


Posted: 2021-04-02 Expires: 2021-05-31

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Senior Regulatory Affairs Specialist (Medical Device)

Kelly Services
Hatfield, PA 19440

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