Lead Regulatory Affairs Expert

2 weeks ago

Minneapolis, Minnesota, United States Laborie Medical Technologies Corp Full time
At Laborie Medical Technologies, we are dedicated to enhancing healthcare and preserving human dignity. Our commitment to making a positive difference in the lives of patients worldwide drives our mission.

We foster an environment that promotes professional growth and a sense of belonging, empowering our employees to achieve their career aspirations while contributing to meaningful work. Our collaborative approach ensures that we tackle challenges together, striving for excellence in all we do. We recognize and reward our team members based on our core values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

Position Overview:

Laborie Medical Technologies is actively seeking a Senior Regulatory Affairs Specialist. This role is crucial for supporting international product registrations and renewals. The specialist will be accountable for maintaining product approvals and managing re-registrations effectively. Additionally, this position involves executing regulatory submission and approval processes for specific Laborie Medical products while ensuring compliance with necessary regulations and corporate standards.

Key Responsibilities:
  • Drafting and preparing documentation for international regulatory submissions and renewals.
  • Identifying global regulatory requirements essential for the approval of assigned products.
  • Implementing product submission strategies as directed by management.
  • Maintaining comprehensive regulatory documentation to facilitate external audits and submission package preparation.
  • Staying informed about current regulatory requirements.
  • Taking on additional responsibilities as assigned by management.
Qualifications:
  • Bachelor's Degree in Science, Engineering, or a related field, along with 4+ years of experience in Regulatory Affairs within the medical device sector.
  • Familiarity with quality system regulations and guidelines.
  • Strong communication skills across all organizational levels.
  • Exceptional organizational and planning abilities.
  • Knowledge of medical devices, procedures, and terminology.
Why Choose Laborie:

Our daily mission is to operate as a premier specialist medical company, advancing technologies that uphold and restore human dignity. We achieve this by assisting individuals with pelvic and gastrointestinal conditions in leading normal lives and ensuring safe deliveries for mothers and babies.

• Paid time off and volunteer opportunities

• Comprehensive Medical, Dental, Vision, and Flexible Spending Account options

• Health Savings Account with company-funded contributions

• 401k Retirement Plan with company matching

• Parental Leave and Adoption Services

• Health and Wellness Programs and Events

Laborie is committed to equal employment opportunities and non-discrimination for all employees and qualified applicants, regardless of race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. We strive to provide access and reasonable accommodations in our services, activities, education, and employment for individuals with disabilities.

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