- Regulatory lead/representative on project core teams providing regulatory input on all matters
- Leads preparation, documentation and submission of FDA and other international applications and providing responses to regulatory agencies regarding device information or issues. Includes the summary of data collected and demonstration of acceptable performance. Ensure understanding of risk and approximate timing for approvals for planning purposes.
- Identifies relevant guidance documents, international regulations and standards and provides interpretive assistance for new filings
- Manages maintenance of device establishment registrations, listings and licensing renewals and ongoing activities for compliance with FDA and other country-specific regulations as required.
- Review all regulatory materials for accuracy, comprehensiveness, and compliance with regulatory standards.
- Provide regulatory guidance and leadership to cross-functional departments or development project teams regarding design, development, evaluation, or marketing (ad/promo) of products.
- Assesses product, manufacturing and labeling changes for regulatory reporting and reviews marketing and sales materials for compliance to regulations.
- Reviews technical reports for incorporation into regulatory submissions
- Manages regulatory affairs procedures to make sure that regulatory compliance is sustained or enhanced.
- Maintain current knowledge of relevant regulations and guidelines both proposed and final rules.
- Manages & leads development of regulatory strategies that meet regulatory requirements and provide guidance regarding regulatory requirements for planned changes.
- Support post-approval products through change evaluation and submission.
-
Consumer Affairs Fulfillment Associate
1 day ago
Land O' Lakes Arden Hills, United States Part timeConsumer Affairs Fulfillment Associate - Part time · Land O'Lakes is seeking to fill a Consumer Relations Fulfillment Associate role with a person who has a customer service mindset and high levels of empathy, patience and professionalism. A passion for baking and/or cooking is a ...
-
Land O'Lakes, Inc. Arden Hills, United States Part timeConsumer Affairs Fulfillment Associate Part time. Land O'Lakes is seeking to fill a Consumer Relations Fulfillment Associate role with a person who has a customer service mindset and high levels of empathy, patience and professionalism. A passion f Fulfillment Associate, Part Tim ...
-
LandOLakes Arden Hills, United States Part timeAs stated in the Land O'Lakes Job Posting policy, all employees who post for an internal opening must inform their current manager at the time they apply. · Our growth relies on our extraordinary talent. Unlock your greatest potential at Land O'Lakes by continuing to make a dif ...
-
Medical Device
1 day ago
Elucent Medical, Inc. Eden Prairie, United StatesJob Title: · Qualifications, skills, and all relevant experience needed for this role can be found in the full description below. · Senior Regulatory Affairs Associate · Reports to: · Vice President – RA and QA · EDUCATION, BUSINESS EXPERIENCE AND PHYSICAL REQUIREMENTS · BA ...
-
Associate Wealth Advisor
1 week ago
Brown Wealth Management Eden Prairie, United StatesWe are a well-established financial services company that is expanding. We offer a great team environment, a reputation for excellence, established clients, and excellent growth potential to help you reach your personal and career goals. · Our employees are as important as our cl ...
-
Associate Wealth Advisor
1 week ago
Brown Wealth Management Eden Prairie, United StatesWe are a well-established financial services company that is expanding. We offer a great team environment, a reputation for excellence, established clients, and excellent growth potential to help you reach your personal and career goals. · Our employees are as important as our c ...
-
Associate Wealth Advisor
1 week ago
Brown Wealth Management Eden Prairie, United StatesWe are a well-established financial services company that is expanding. We offer a great team environment, a reputation for excellence, established clients, and excellent growth potential to help you reach your personal and career goals. · Our employees are as important as our c ...
-
Principal Systems Engineer
2 days ago
ACIST Medical Systems Eden Prairie, United StatesJob Description · The Principal Systems Engineer position is a key technical leadership role at BMT and will integrate inputs and outputs to support the definition and development of complex software systems involving software services and multiple electro-mechanical medical dev ...
-
Associate Wealth Advisor
1 day ago
Brown Wealth Management Eden Prairie, United StatesWe are a well-established financial services company that is expanding. We offer a great team environment, a reputation for excellence, established clients, and excellent growth potential to help you reach your personal and career goals. · Our employees are as important as our c ...
-
Principal Systems Engineer
1 week ago
ACIST Medical Systems Eden Prairie, United States Full timeJob Description · The Principal System Engineer position is a key technical leadership role at BMT and will integrate inputs and outputs to support the definition and development of complex software systems involving software services and multiple electro-mechanical medical devic ...
-
Paralegal or Sr Legal Services Specialist
1 week ago
UnitedHealth Group Inc. Minnetonka, United StatesUnitedHealth Group is a health care and well-being company that's dedicated to improving the health outcomes of millions around the world. We are comprised of two distinct and complementary businesses, UnitedHealthcare and Optum, working to build a better health system for all. H ...
-
Systems Analyst
1 week ago
Unisys Hopkins, United StatesJOB DESCRIPTION We Believe in Better We are a global information technology company that builds high-performance, security-centric solutions that can help change the world. Enhancing people's lives through secure, reliable advanced technology is our vision. At Unisys, we believe ...
-
Part-Time Sales Associate, Edina
1 week ago
Parachute Home Hopkins, United States Part time**Part-Time Sales Associate, Edina** · at Parachute Home Edina, MN We are seeking a positive, hardworking, customer-facing Part-Time Sales Associate for our upcoming Edina store · RESPONSIBILITIES · Provide best-in-class customer care and elevated service. · Deliver a positiv ...
-
Part-Time Sales Associate
1 week ago
Shinola Hopkins, United States Part time**Part-Time Sales Associate** · at Shinola- Retail Edina, Minnesota **What you'll do:** · Become an expert on our brand and products · Create community with our guests by providing the best customer service · Create community with your team by embodying our brand values · Bu ...
-
Clinical Research Associate
1 week ago
Danaher Corporation Chaska, United StatesAt first glance, you will see that for more than 80 years we have been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We are building a culture that celebrates ...
-
Clinical Research Associate
1 week ago
Beckman Coulter Chaska, United StatesAt first glance, you will see that for more than 80 years we have been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We are building a culture that celebrates ...
-
Senior Clinical Research Associate
1 week ago
Danaher Corporation Chaska, United States Paid WorkAt first glance, you will see that for more than 80 years we have been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We are building a culture that celebrates ...
-
Senior Clinical Research Associate
1 week ago
Danaher Chaska, United States Full timeAt first glance, you will see that for more than 80 years we have been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We are building a culture that celebrates ...
-
Regulatory Affairs Analyst II
1 week ago
Danaher Corporation Chaska, United StatesWondering what's within Beckman Coulter?Take a closer look. · At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and alw ...
-
Regulatory Affairs Analyst II
2 weeks ago
Danaher Corporation Chaska, United StatesWondering what's within Beckman Coulter? Take a closer look. · At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and alw ...
Senior Regulatory Affairs Associate - Eden Prairie, United States - Elucent Medical, Inc.
Description
Job Title:
Senior Regulatory Affairs Associate
Reports to:
Vice President RA and QA
EDUCATION, BUSINESS EXPERIENCE AND PHYSICAL REQUIREMENTS
BA/BS degree (preferably in Regulatory Sciences)
Minimum 5 years of medical device Regulatory Affairs
Proven track record with regulatory submissions.
Experience preparing & defending regulatory submissions to the FDA (510(k)
Knowledge of global regulatory requirements including EU, Canada and Asia.
Demonstrated experience of basic engineering principles; electrical, mechanical and software
Proven effective collaboration with regulatory agencies
Ability to apply critical thinking on current global regulatory science questions.
Individual must have a hands-on approach
Strong organizational and time management skills
Excellent technical/computer skills
REQUIRED COMPETENCIES
Leadership:
Recognized as a technical leader within the company and maintains positive attitude when working with peers, customers or suppliers
Capable of leading a project team in fulfillment of regulatory requirements for a given product and/or geography
Works effectively on cross functional teams
Communication
Excellent written and oral communication skills
Ability to formulate responses to common inquiries from regulatory agencies
DESCRIPTION OF RESPONSIBILITIES
The Senior Regulatory Affairs Associate will support the definition of the regulatory strategy for Elucent products. This position will play a substantial role researching regulations, defining and implementing the regulatory strategy and engaging with health authorities to effectively inform our development programs. The successful candidate should possess a scientific background and will have an understanding of electromechanical devices. The ability to deal with ambiguity and think outside the box are critical for this position.
KEY RESULT AREAS
Other duties as assigned.