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Regulatory Affairs Manager - Remote

Employer
Aerotek
Location
Minneapolis
Salary
Competitive

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Job Responsibilities:
1. Assess proposed regulations and communicate new requirements to the organization.
2. Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.
3. Coordinate activities related to domestic and international regulatory submission and approval for medical software solutions.
4. Monitor compliance of company policies and procedures to international regulations (FDA QSR, EU MDR)
5. Assist with revisions to company policies and procedures to ensure compliance
6. Support the product development teams in the implementation of regulatory requirements, including review of design and test documentation
7. Prepare, contribute, plan and/or manage the preparation of post-market surveillance plans and evaluate post-market data
8. Prepare, contribute, plan and/or manage the preparation of HFE and Clinical Evaluation deliverables
9. Assist with maintenance of the quality management system
10. Stay abreast of current and novel developments in the field
11. Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills
12. Demonstrates effective change leadership

Experience and Qualifications:

- 7+ years of Regulatory Experience or an equivalent combination education and work experience

- Bachelor's Degree (Advanced Degree preferred)

Skills:

- Demonstrates effective change leadership

- Builds strategic partnerships to further departmental and organizational objectives

- Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.

- Experience with Software as a Medical Device (SaMD).

- Some experience with regulatory cybersecurity requirements preferred.




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing ?? Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call or email .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

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