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Regulatory Affairs Lead - IVD/Med Device

  • Location: Madison, Wisconsin
  • Type: Direct Hire
  • Job #2958

Are you looking to use your Regulatory experience within IVD or Medical Devices at an admired company you can grow and be valued in? This could be the perfect role for you!

What You'll Do:

The Regulatory Affairs Lead will be an important part of the in vitro diagnostic new product development and realization teams from start to finish, making sure all regulatory compliance is met. You will work with cross-functional teams and external providers to ensure that the new and existing products comply with international standards and regulations. Demonstrated regulatory affairs experience with IVD/Medical Devices is crucial for this position..

Key responsibilities involve serving as the Regulatory Affairs Subject Matter Expert on New Product Development Teams for In Vitro Diagnostic Medical Device Projects, which include:
1. In collaboration with RA leadership and subject matter experts, evaluate regulatory impact of proposed products.
2. Research and evaluate regulatory requirements.
3. Provide regulatory guidance and assess regulatory implications for products throughout the product lifecycle.
4. Work with cross-functional teams to prepare regulatory applications, registrations, and submissions to regulatory authorities.
5. Maintain documentation needed to support regulated product throughout the product’s lifecycle.
6. Review and approve product labels (label disclaimers).
7. Review and approve product literature for compliance to applicable regulations.
8. Facilitate risk assessments for regulated products.
9. Evaluate risks based on regulatory factors, provide options and recommendations to mitigate risk.
10. Organize, facilitate, or lead meetings to discuss review findings and planning issues.
11. Provide regulatory support for other branches as needed.
12. Develop and conduct regulatory training, as needed.
13. Assist with writing SOPs as needed.
14. Provide regulatory input for complaint investigations and product recalls.
15. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
16. Embracing and being open to incorporating the company's Emotional & Social Intelligence (ESI) core principles in daily work.
17. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

What You'll Bring:

1. Bachelor’s degree in life science, chemistry, or other relevant field.
2. Minimum of 5 years regulatory experience with a graduate degree or 8 years quality regulatory work experience with a bachelor’s degree.
3. Good understanding of applicable FDA regulations and EU Directives.
4. Experience in writing and reviewing documents required to support regulated products.
5. Proficiency with basic word processing and spreadsheet software programs.
6. Ability to develop concise, clear communication and presentations that contain both analysis and possible solutions.
7. Proven ability to work effectively with a broad range of people, both internally and externally, to achieve results.
8. Effective communication skills.

Ideal (but not required) Qualifications:
1. Regulatory Affairs Certification (RAC).
2. Experience in developing EU Technical Files to support regulated product.
3. Experience in developing compliance files or submissions to support regulated product in other markets.
 

Apply Now and move your career forward with an exciting and highly respected biotech leader!
Questions? Contact Andie Veach directly at Andie@CarexScientific.com

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.

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