Regulatory Affairs Associate (Maplewood, MN) Job

3M

(Saint Paul, Minnesota)
Full Time Travel Required
Job Posting Details
About 3M
3M is science applied to life. At 3M, we are in your cell phone. We are in your car. We are at your doctor’s office. You are never more than 10 feet from a 3M product. 3M helps make it possible for many other companies to do what they do.
Summary
The person hired for the position for the Regulatory Affairs Associate wilI lead medical device and combination product registration activities globally.
Responsibilities
- Provide regulatory leadership for new product development and change management activities. - Compile, prepare regulatory documents (summary technical documents, essential requirements checklists, 510(k)’s, EU design dossiers) - Develop product registration strategies that enable accelerated product development through knowledge of FDA regulations, European Union (EU) Directives, International Organization for Standardization (ISO) standards, etc. - Provide support on special regulatory assignments relating to the development of internal procedures, training, interpretation of existing and new international regulations - Plan and execute global product registrations on time - Review product design, label, manufacturing location or other changes for impact on product registrations - Review product labeling and claims for compliance to applicable regulations - Assure regulatory compliance in all activities
Ideal Candidate
**Basic Qualifications:** - Bachelor’s degree or higher in a Science or Engineering discipline from an accredited university - Minimum of one (1) year of experience regulatory affairs related to combination products and medical devices (a graduate project is considered qualifying) **Preferred Qualifications:** - Bachelor’s degree or higher in Pharmacy, Engineering, Biological Sciences, Chemistry or related discipline from an accredited university - Minimum of two (2) years of regulatory experience interacting with FDA and/or other regulatory bodies worldwide - Knowledge of or experience with tissue and/or biologic regulations - Demonstrated technical/scientific skills, excellent technical communication skills (oral and written), effective interpersonal and organizational skills and the ability to meet deadlines - Demonstrated history of accomplishments and contributions to business in previous assignment in support of regulated products - Proven project leadership and excellent communication skills - RAC certification - Bilingual (English and Spanish or Chinese-Mandarin) a plus - Microsoft Office proficient
Compensation and Working Conditions
Benefits Benefits not included

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