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Tempus

Senior Quality Engineer

Chicago, IL · On-site

Be involved in the medical device software design controls activities, in accordance with the FDA ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

Tempus

Senior Quality Engineer

Chicago, IL · On-site +1

Be involved in the medical device software design controls activities, in accordance with the FDA ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

Tempus

Senior Quality Engineer

Redwood City, CA · On-site +1

Be involved in the medical device software design controls activities, in accordance with the FDA ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

Tempus

Senior Quality Engineer

New York, NY · On-site +1

Be involved in the medical device software design controls activities, in accordance with the FDA ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

Integer

Senior Regulatory Affairs Specialist

Plymouth, MN

$113.03K - $165.77K/yr

... are open and honest with one another Integrity We do the right things and do things right The ... Ensures relevant International, ISO and FDA Export requirements are met, as required and ensures ...

Ironside Human Resources

Mammographer

Gallup, NM

$60K - $80K/yr

Strong knowledge of breast anatomy, positioning techniques, and MQSA/FDA compliance standards with ... Surrounded by beautiful natural landscapes and wide-open spaces * Ideal setting for professionals ...

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What are the key skills and qualifications needed to thrive in FDA job openings, and why are they important?

To thrive in FDA job openings, candidates typically need a strong background in science, regulatory affairs, and analytical skills, often with a relevant degree in biology, chemistry, pharmacy, or related fields. Familiarity with regulatory databases, submission systems (such as eCTD), and certifications like RAC (Regulatory Affairs Certification) are highly valued. Attention to detail, effective communication, and the ability to work collaboratively are essential soft skills for success. These competencies ensure regulatory compliance, thorough review of submissions, and effective teamwork in safeguarding public health.

What are some common challenges faced by professionals starting in FDA roles, and how can applicants prepare for them?

Professionals beginning their careers at the FDA often encounter challenges such as adapting to complex regulatory frameworks, working with cross-disciplinary teams, and managing the pace of policy changes. To prepare, applicants should familiarize themselves with FDA guidelines and regulatory processes, develop strong communication skills to collaborate effectively with scientists, regulators, and industry representatives, and stay updated on current public health issues. Proactive learning and seeking mentorship within the organization can also ease the transition and foster professional growth.

What are FDA openings?

FDA openings refer to job opportunities or vacancies at the U.S. Food and Drug Administration (FDA). The FDA is a federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other related products. These openings span a wide range of roles, including scientists, inspectors, analysts, administrative professionals, and more. Candidates can find current job listings and application instructions on the official USAJOBS website and the FDA’s careers page. Working at the FDA offers the chance to contribute to public health and safety at a national level.
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Regulatory Affairs Project Manager

Regulatory Affairs Project Manager

DEKA Research & Development

Manchester, NH • On-site

Full-time

Posted 18 days ago

Job description

DEKA Research & Development has an immediate opening for a Regulatory Affairs Project Manager to contribute to a dynamic, medical device research and development environment. The individual in this high visibility role will have a significant and direct impact on the success of the innovative life science devices that DEKA develops. The person in this role will formulate and execute regulatory strategies to deliver FDA approval or clearance as well as international approvals including CE Marking.
How you will make a difference as a Regulatory Project Manager: 
  • Work in close association with customers and development teams to define and execute regulatory approval and clearance programs, including establishing regulatory requirements and leading the preparation and submission of 510(k)s, PMAs, IDEs, Technical Files, and other international dossiers
  • Provide leadership and guidance to R&D in developing successful regulatory strategies across the entire product life cycle
  • Mentor regulatory affairs staff, as well as internal cross-functional partners, on effective regulatory strategies and tactics
  • Lead FDA interactions including in-person meetings, teleconferences, written submissions and other Agency engagements as needed
  • Participate in the design and conduct of clinical trials, and assist in obtaining and maintaining the appropriate regulatory approvals from the FDA, IRBs and/or Ethics Boards
  • Continually improve internal regulatory processes and procedures to increase efficiency and reduce time to market while maintaining the highest levels of compliance
Skills you will need to be successful: 
  • BS in a technically related field
  • Minimum of 5 years direct work experience in a medical device, drug or biologic regulatory role with demonstrated success in obtaining product approvals/clearances
  • Experience in direct FDA interactions including premarket notifications, IDE’s, Q-submissions and participation in face-to-face meetings
  • Strong written and verbal communication skills
  • Demonstrated ability to continually balance priorities in a dynamic and fast-paced environment
  • Expertise in current FDA processes including the eSTAR submission tool, establishment registration and listing, UDI, product labeling, and post-market reporting including MDR’s and Field Action Reporting
  • Experience in Medical Device Quality Regulations including Quality Management Systems Regulations (QMSRs), ISO 13485, and MDSAP
  • Demonstrated ability in expanding regulatory organization capabilities
  • Experience with drug, biologic and combination product approvals a plus
  • RAC certification a plus

About DEKA:

One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.

Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.


 

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