Sr. Regulatory Affairs Specialist

Cepheid Hatfield , PA 19440

Posted 3 weeks ago

Essential Duties and Responsibilities:

  • 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 customer practices;

  • 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 company's 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 dealer 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 company's quality system to reflect current requirements and state-of-the-art;

  • Assist/support/participate, as appropriate, with regulatory inspections and third-party audits;

  • Review company 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 company's medical devices, as needed;

  • Maintain systems and ensure timely submission of licenses and applications to authorities, adhering to strict deadlines;

  • Work with engineering to specify storage, label and package requirements;

  • Assist Engineering and/or other functional groups in prototype development, evaluation and documentation;

  • Performs other duties and tasks as assigned by management.

  • Other duties as assigned

REQUIREMENTS:

  • BS degree in a technical field

  • Minimum of 2 years of Regulatory Affairs experience or MS degree in Regulatory Affairs

PREFERRED SKILLS:

  • Proficient use of computers, MS Office (Word, Excel & PowerPoint)

  • SAP experience desired; RAC certification highly desired.

  • Superior written, verbal, interpersonal communications

  • Strong interpersonal communications, ability to lead teams and to work within teams;

  • Goal oriented, results driven

  • Ability to organize information and present to a wide array of audiences;

  • Ability to analyze and assimilate data including engineering drawings, specifications, labeling, statutory and regulatory requirements;

  • Self-motivated and able to work with minimum supervision

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.

#LI-CY1

IND-KAV1


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Sr. Regulatory Affairs Specialist

Cepheid