Regulatory Affairs Lead
Our client, a leading organization in the medical device and pharmaceutical industry, is seeking a Regulatory Affairs Lead to join their team. As a Regulatory Affairs Lead, you will be part of the Laboratory / Technical Family supporting regulatory and environmental compliance initiatives. The ideal candidate will have strong analytical skills, excellent communication abilities, and a proactive approach, which will align successfully in the organization. Job Title: Regulatory Affairs Lead Location: Maplewood, MN Duration: 3 months (Potential to extend) What's the Job?
- Lead regulatory and environmental compliance activities within the organization, ensuring adherence to applicable regulations and standards.
- Support the development and implementation of regulatory strategies for product approvals and post-market changes.
- Coordinate and conduct global regulatory change assessments and manage associated activities for assigned products.
- Assist in risk management activities, vigilance reporting, and other quality initiatives with minimal oversight.
- Communicate technical results effectively to cross-functional teams through reports, presentations, and documentation.
What's Needed?
- Bachelor’s Degree in a scientific discipline such as Chemistry or Chemical Engineering.
- Minimum of five (5) years of experience in regulatory affairs within the pharmaceutical or medical device industry, including experience with combination medical devices.
- Experience authoring regulatory submissions, technical documentation, and regulatory strategies.
- Proficiency in regulatory support for wound dressings, surgical products, or related medical devices.
- Strong organizational skills, stakeholder management, and proficiency in Office Suite and Regulatory Management Software.
What's in it for me?
- Opportunity to work with a diverse and innovative global team.
- Engage in impactful projects that influence regulatory strategies and product development.
- Develop your professional skills in a dynamic environment.
- Be part of a company committed to compliance and quality excellence.
- Remote work flexibility within the United States.
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. Apply tot his job Apply To this Job