Senior Consultant and Regulatory Affairs

Our client, a medical device and connected health organization, is seeking a Senior Consultant and Regulatory Affairs to join their team.

Job Title: Senior Consultant and Regulatory Affairs

Location: Fully remote

Duration: 7+months with the possibility of extension/conversion

Pay Range: $64.25

What's the Job?

• Serve as the Regulatory Affairs core team representative for Connected Monitoring and Respiratory Health products, including associated software.

• Execute EU MDR regulatory activities for product changes, lifecycle management, technical documentation, and compliance initiatives.

• Assess design changes to determine EU MDR regulatory impact, identify compliance gaps, and evaluate associated risks.

• Prepare, review, and maintain EU MDR technical documentation and regulatory deliverables to support ongoing compliance.

• Support EU MDR submissions and ongoing interactions with Notified Bodies and regulatory authorities as required.

What's Needed?

• Bachelor's degree in a scientific, engineering, regulatory, or related discipline (or country equivalent).

• Minimum 5 years of Regulatory Affairs experience within the medical device industry.

• Strong hands-on experience with EU MDR regulations and compliance requirements, including technical documentation and product lifecycle activities.

• Experience supporting electro-mechanical medical devices with embedded software and conducting product change assessments.

• Demonstrated ability to identify compliance risks and develop clear regulatory assessments, justifications, and documentation.

What's in it for me?

• Work on EU MDR compliance and product lifecycle activities for complex connected monitoring and respiratory health medical devices.

• Collaborate directly with Engineering, Quality, Clinical, Medical, and Marketing teams to integrate regulatory requirements into deliverables.

• Contribute to cross-functional design change management and global regulatory strategy within a highly collaborative Regulatory Affairs team.

• Take ownership of EU MDR technical documentation, change assessments, and submission-related responsibilities.

• Join a team of approximately 28 Regulatory Affairs professionals with strong focus on connected monitoring product lines.

Regards ,

Manna Jaspher

Executive - Talent Acquisition

Experis IT - Manpower Group

Office: 414-446-3178

[email protected]

www.experis.com

Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans

• Dental Plan

• Vision Plan

• Health Savings Account

• Health Flexible Spending Account

• Dependent Care Flexible Spending Account

• Supplemental Life Insurance

• Short Term and Long Term Disability Insurance

• Business Travel Insurance

• 401(k), Plus Match

• Weekly Pay

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 2023 ManpowerGroup was named one of the World's Most Ethical Companies for the 14th 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.