Regulatory Affairs Specialist

Integrated Resources Inc.; Salt Lake City (UT); On-site; USD 70,000 - 90,000; Full time

Job summary

Integrated Resources Inc. seeks a Regulatory Affairs Specialist to ensure compliance with US and foreign regulations in the medical device sector. The role involves preparing and submitting regulatory documents, managing confidentiality, and requires strong project management and communication skills. Ideal candidates will possess a science degree and have 4-6 years of regulatory experience, with an emphasis on foreign approvals of higher-risk medical devices.

Qualifications

• Minimum 4-6 years of experience in regulatory activities.
• Experience with foreign regulatory approval/clearance preferred.
• Desirable RAC certification for the role.

Responsibilities

• Prepare and submit regulatory documentation for medical devices.
• Exhibit competence in US & foreign regulations related to medical device manufacture.
• Manage proprietary information with confidentiality.

Skills

Project Management

Problem Solving

Communication

Decision Making

Education

Bachelor's degree in science, biomedical engineering, medical/scientific writing, or public health administration

Advanced degree

Regulatory Affairs Certification (RAC)

Job description

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

Regulatory Affairs Specialist position:

1. Exhibit competence in US & foreign government regulations regarding the manufacture & distribution of medical devices.
2. Assist with activities necessary for the timely preparation, writing, and submission of international registrations (technical files), including all related amendments & supplements. EU experience with Dossiers and technical files is a plus.
3. Prepare, write, and file regulatory documentation efficiently.
4. Manage a significant amount of proprietary information with strict confidentiality.
5. Possess strong project management skills.
6. Have good oral communication skills for presentations and meetings.
7. Work as a self-starter, effectively with minimal supervision.
8. Demonstrate strong problem-solving and priority-setting abilities.
9. Make informed decisions daily, based on regulatory expertise, government constraints, and business needs.

Qualifications

Education requirements:

1. Bachelor's degree from an accredited college or university in science, biomedical engineering, medical/scientific writing, or public health administration.
2. An advanced degree is desirable.
3. Regulatory Affairs Certification (RAC) by the Regulatory Affairs Professional Society is desirable.
4. Experience with foreign regulatory approval/clearance of medical devices, especially higher risk devices, is preferred.
5. Typically 4-6 years of successful experience in regulatory activities that achieved domestic and international approvals.

Additional Information

Thank you!
With regards,
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Direct: 732-662-7964 | (W) 732-549-2030 x219

Inc. 5000 – 2007-2015 (9 Years in a row)