"Alerted.org

Our client, a leading organization in the medical device industry, is seeking a **Regulatory Affairs Specialist** to join their team. As a Regulatory Affairs Specialist, you will be part of the Regulatory Affairs Department supporting product development and global compliance activities. The ideal candidate will have strong analytical skills, excellent communication abilities, and a collaborative mindset which will align successfully in the organization.

**Job Title:** Regulatory Affairs Specialist

**Location:** Cleveland, OH (Hybrid – three days per week in office)

**Pay Range:** $44.59 - 47.29

What’s the Job?

+ Provide regulatory input during product development to ensure compliance with global regulatory requirements.

+ Prepare and submit regulatory submissions such as 510(k)s, MDR EU Technical Files, and other international filings.

+ Evaluate product changes to determine regulatory impact and manage license renewals to maintain market authorization.

+ Review and approve advertising and promotional materials to ensure regulatory compliance.

+ Support audits, inspections, and continuous improvement of regulatory processes.

What’s Needed?

+ Bachelor’s degree in a scientific, engineering, legal, or life sciences field.

+ 4+ years of experience in a regulated industry, preferably in Regulatory Affairs or medical devices.

+ Strong written and verbal communication skills in English.

+ Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).

+ Proven problem-solving and project management skills with a collaborative approach.

What’s in it for me?

+ Medical insurance

+ Dental insurance

+ Disability insurance

+ Life insurance

+ Weekly payment

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of:** **Manpower, Experis, Talent Solutions, and Jefferson Wells

_ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands –_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _–_ creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.