Regulatory Affairs Specialists III

Integrated Resources Inc.; Milwaukee (WI); On-site; USD 65,000 - 85,000; Full time

Job summary

A leading company is seeking a Regulatory Affairs Specialist in Milwaukee. This individual will be crucial in managing product compliance, participating in new product introductions, and ensuring regulatory submissions meet necessary guidelines. The ideal candidate will possess strong communication skills, a relevant degree, and experience in a regulated industry, contributing towards maintaining high-quality standards in product development.

Qualifications

• Minimum 1 year experience in a regulated industry required.
• 3 years experience preferred.
• Experience communicating effectively in technical settings.

Responsibilities

• Participate in new product introductions and communicate product changes.
• Review advertising material for regulatory compliance.
• Research and document regulatory submission requirements.

Skills

Effective communication in English

Attention to detail

Team-oriented

Education

Bachelor's Degree

Advanced degree in scientific, technology or legal disciplines

Regulatory Affairs Certification (RAPS)

Statistics education and/or training

Tools

MS Office

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

1. Participate as a team member on all assigned new product introductions as applicable.
2. Communicate changes in existing products to applicable RA representatives for determination of the need for new/revised licenses or registrations.
3. Review and approve advertising and promotion material ensuring it is consistent with approved claims for regulated products.
4. Partner with applicable RA representatives for countries with license expiration requirements, to establish plans and deliverables for timely submission for renewal of licenses.
5. Identify any clinical data requirements for product licensing globally and ensure the requirements are documented in the compliance plan.
6. Complete specific country testing and work with Region RA, and arrange for test devices and support as needed.
7. Contribute to writing and editing technical documents.
8. Research, analyze, integrate, and organize background information from diverse sources for regulatory submissions.
9. Understand and apply regulatory requirements and their impacts for submissions.
10. Ensure compliance with pre- and post-market product approval requirements.
11. Support regulatory inspections as required.
12. Perform a broad variety of tasks in support of product and process design as assigned by the departmental manager.

Qualifications

1. Bachelor's Degree or a minimum of 4 years work experience.
2. Minimum of 1 year experience working in a regulated industry.
3. Ability to communicate effectively in English (both written and oral).
4. Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
5. Quality Specific Goals:
6. Aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
7. Complete all planned Quality & Compliance training within the defined deadlines.
8. Identify and report any quality or compliance concerns and take immediate corrective action as required.
9. Characteristics:
10. Minimum of 3 years’ experience in a regulated industry is preferred.
11. Advanced degree in scientific, technology or legal disciplines.
12. Regulatory Affairs Certification (RAPS).
13. Statistics education and or training.
14. Ability to work independently in a fast-paced environment with little supervision.
15. Ability to adapt to constant change and influence positive change effectively.
16. Team-oriented and responsive to customer needs.
17. Attention to detail and results-oriented.
18. Ability to understand technical documentation and execute associated procedures.