Director, Regulatory

2 months ago

HOPKINSMinnesotaUS, United States Michael Foods Inc. Full time
Business Unit Overview:

Michael Foods, Inc. is a leader in the food processing and distribution industry with business in egg products, refrigerated grocery and potato products. We offer exciting job possibilities throughout our organization where you can enhance your career, sharpen your talents and make an impact. Join our company and be part of an innovative team that’s First in Food.

Location Description:

Hopkins, MN is home to our Michael Foods, Inc. corporate headquarters. Hopkins is located 7 miles west of Minneapolis, boasting natural surroundings in a suburban environment that also provides quick access to major travel ways and local restaurants that give our community a distinct character. Located in the Excelsior Crossing building where employees are provided with beautifully landscaped walking paths and water features creating an optimal environment for outdoor and walking meetings, along with the opportunity to take a relaxing walk or outdoor lunch before, within, or after your work day.

Responsibilities:

The Director of Regulatory Affairs and Customer Compliance is responsible for overseeing and providing leadership for all regulatory and export compliance matters within the MFI Integrated Supply Chain.  The position must effectively collaborate with all functional groups within the business, its customers, and external governmental agencies, primarily the FDA, USDA FSIS, USDA FAS, and USDA AMS.  The position will work to identify opportunities to impact policy at a national and political level to enhance the value to the business and its customers.

 

In addition to providing leadership and oversite for regulatory compliance, this position has responsibility for overseeing the Food Safety and Quality Customer Care and Compliance department.  This department is responsible for ensuring compliance with customer requirements and expectations, developing responses to customer concerns, and acting as the liaison between the customer and the manufacturing facilities. 

 

The position will report to the VP of FSQ.

 

DUTIES AND RESPONSIBILITIES:

  • Seek out and drive opportunities to add value to the business by impacting the development of regulatory policy, and governmental execution of policy, at a national and political level.
  • Support the annual internal FSQ assessment process at all MFI facilities through verification of compliance to applicable food safety related regulatory requirements.
  • Solicit, assess, draft, and submit value added project requests to the USDA FSIS New Technology group based on current and forthcoming regulations and/or process changes. Once approval is granted, monitor and submit data to the New Technology group in compliance with each specific waiver and letter of no objection that is obtained.
  • Provide expertise and guidance regarding all customer and country required export documentation. This includes, but is not limited to, regulatory forms and letters, pro forma invoices, commercial invoices, packing lists, letters of credit, bank drafts, shippers export declaration/electronic export information, letters of instructions, Free Trade (NAFTA) Certificates, Certificates of Origin, Certificates of Analysis, “Food” Re-Export Certificates, USDA certificates, Proof of Delivery, and Bills of Lading.
  • Solicit, draft, assess and submit comments to all applicable FDA and USDA proposed rules and guidance documents.
  • Maintain all company and facility food safety related regulatory permits and approvals (e.g. - Grants of Inspection, Food Facility Registrations, Off-Premise Freezing Permits, Alternative Shipment Protocols, Forms 5200-6 for Export Certification, Voluntary Inspection, organizational chart updates, AMS Form LPS109, AMS PEEPEV approved products and plants lists, Voluntary PY200s for domestic shipments, etc.).
  • Develop and maintain positive relationships with all internal functions and applicable regulatory agencies, while leading the management of any regulatory related issues that may arise at a plant or corporate level.
  • Support the MFI manufacturing facilities through the interaction of regulatory bodies, where appropriate. Assist in developing written responses to non-conformances identified by USDA and FDA.
  • Research regulations for a wide spectrum of applications, including, but not limited to, product development, ingredients use, animal disease, labeling, USDA challenges and appeals, and export compliance, for all MFI functions and facilities.
  • Monitor various regulatory web sites (e.g. FSIS Export Library and FSMA), attend regulatory meetings and webinars, receive and review automatic notifications (e.g. FSIS, FDA, AMS, APHIS, OIE, Federal Registry), participate in industry groups and associations, and personally interact with regulatory officials to maintain an awareness of regulatory policy changes and an understanding of how it may affect the Integrated Supply Chain (ISC).
  • Research countries’ import requirements, educating the sales force and the functions within supply chain on those requirements. Monitor existing countries’ continually changing requirements.
  • Oversee the Customer Compliance department. Set goals and drive improvements which will support the team in ensuring compliance to customer expectations.
  • Support the Customer Compliance team in the maintenance of customer required databases and information requests.
  • Ensure that all customer complaints and concerns are appropriately investigated, and that appropriate responses are developed to support sales in effectively maintaining strong relationships with the MFI customer base.
  • Ensure compliance with labeling requirements, claims (e.g. Kosher, Halal, Cage Free, etc) and state regulations (e.g. California Proposition 12, 65).
Qualifications:

EDUCATION AND EXPEREINCE REQUIRED:

 

  • Bachelor’s degree in business or a related field.
  • A minimum of 10 years of experience in food related regulatory/compliance management is preferred.
  • Experience working with federal and state agencies in food manufacturing organizations.
  • Ability to work independently using sound judgment, legal research and organizational skills.
  • Must have excellent interpersonal, verbal, written and presentation skills.
  • Must be able to work with individuals at all levels of the organization.
  • Must have proficiency with computer skills (such as Microsoft Office suite); experience developing and maintaining user databases for technical information and standardized forms is highly preferred.
  • Must demonstrate adherence to ethical standards at all times.
  • Knowledgeable and able acting in strict accordance with the requirements of all relevant laws, regulations, and Company policies, including, among other areas, Food and Drug Administration regulations.
  • An extensive knowledge of food related regulations and the applicable regulatory bodies (e.g. – FDA and USDA).
  • Self-motivated with the ability to prioritize and multi-task.
  • Ability to lead and be a contributing member of cross functional teams.

 

 

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

  • Successful project management experience preferred.
  • Business acumen, innovation, strategic thinking, professionalism, visionary leadership and problem-solving skills are beneficial.

  • Regulatory Affairs Director

    4 days ago

    Hopkins, Minnesota, United States Post Holdings Full time

    Job Title: Regulatory Affairs DirectorPost Holdings is seeking a highly skilled Regulatory Affairs Director to oversee and provide leadership for all regulatory and export compliance matters within the company's Integrated Supply Chain.The ideal candidate will have a strong background in food-related regulatory compliance management and experience working...

  • Regulatory Affairs Director

    1 week ago

    Hopkins, Minnesota, United States Michael Foods Inc. Full time

    Job Title: Regulatory Affairs DirectorJob Summary:We are seeking a highly skilled Regulatory Affairs Director to join our team at Michael Foods, Inc. The successful candidate will be responsible for overseeing and providing leadership for all regulatory and export compliance matters within the MFI Integrated Supply Chain.Key Responsibilities:* Collaborate...

  • Director, Regulatory Affairs and Compliance

    4 weeks ago

    Hopkins, Minnesota, United States Michael Foods Inc. Full time

    Job Title: Director, Regulatory Affairs and ComplianceMichael Foods, Inc. is a leading food processing and distribution company with a strong commitment to regulatory compliance and food safety. We are seeking a highly skilled and experienced Director, Regulatory Affairs and Compliance to join our team.Key Responsibilities:Develop and implement regulatory...

  • Director of Regulatory Affairs and Compliance

    2 weeks ago

    Hopkins, Minnesota, United States Michael Foods Inc. Full time

    Director of Regulatory Affairs and ComplianceMichael Foods, Inc. is a leading food processing and distribution company with a strong presence in the industry. We are seeking a highly skilled Director of Regulatory Affairs and Compliance to join our team.Key Responsibilities:Oversee and provide leadership for all regulatory and export compliance matters...

  • Regulatory Affairs Director

    3 days ago

    Hopkins, Minnesota, United States Post Holdings Full time

    Job Title: Regulatory Affairs DirectorJob Summary:The Director of Regulatory Affairs and Customer Compliance is responsible for overseeing and providing leadership for all regulatory and export compliance matters within the MFI Integrated Supply Chain.The position must effectively collaborate with all functional groups within the business, its customers, and...

  • Director, Regulatory

    5 months ago

    Hopkins, United States Michael Foods Inc. Full time

    Business Unit Overview: Michael Foods, Inc. is a leader in the food processing and distribution industry with business in egg products, refrigerated grocery and potato products. We offer exciting job possibilities throughout our organization where you can enhance your career, sharpen your talents and make an impact. Join our company and be part of an...

  • Director of Regulatory Strategy

    2 weeks ago

    US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full time

    Job Title: Director, Global Regulatory LeadThe Director, Global Regulatory Lead is responsible for providing strategic direction and guidance for product development and regulatory submissions. This role will serve as the key corporate regulatory contact and source of regulatory information and guidance for the US market and other markets as applicable.Key...

  • Strategic Regulatory Affairs Director

    1 week ago

    US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs StrategyThe position will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs. The individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with...

  • Senior Director Regulatory Affairs Strategy Lead

    2 weeks ago

    US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full time

    Regulatory Affairs Strategy Senior Director OpportunitySun Pharmaceutical Industries, Inc. is seeking a highly experienced Senior Director to lead our Regulatory Affairs Strategy team. As a key member of our global regulatory affairs team, you will be responsible for developing and executing the overall regulatory strategy for our novel drug development...

  • Director, Safety and Regulatory Compliance

    2 months ago

    Fort Worth/Texas/US ITS Technology and Logistics, LLC Full time

    Overview: The Director, Safety and Regulatory Compliance is responsible for the successful development, implementation, maintenance, communication and training of an effective Safety program, to include accident and incident investigations, data analysis and recurrence prevention processes for ConGlobal.  This person will ensure all locations are...

  • Executive Director, Legislative and Regulatory Policy Solutions

    1 week ago

    Minnesota, United States 001_BCBSA Blue Cross and Blue Shield Association Full time

    Job SummaryWe are seeking a highly experienced and skilled Executive Director to lead our legislative and regulatory policy efforts. As a key member of our team, you will be responsible for advancing BCBSA's policy solutions and market positioning in Medicare, Medicaid, Duals, and Children's Health Insurance Program.Key ResponsibilitiesStrategic Policy...

  • Senior Director of Compliance and Vendor Oversight

    1 week ago

    Hopkins, Minnesota, United States Medica Full time

    Job SummaryWe are seeking a highly experienced Senior Director of Compliance and Vendor Oversight to join our team at Medica. As a key member of our compliance leadership team, you will be responsible for providing strategic guidance and oversight to ensure the effective implementation of our compliance program.The ideal candidate will have a strong...

  • Global Regulatory Lead

    1 week ago

    US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full time

    The Director of Regulatory Strategy will be responsible for leading the development and execution of regulatory strategies for assigned brand programs. This includes providing regulatory pathways for product development, reviewing clinical, non-clinical, and CMC development as needed, and acting as the US agent for communication with regulatory agencies. The...

  • Engineer, Prin Regulatory

    2 weeks ago

    OSWEGO/New York/US Constellation Energy Full time

    WHO WE AREAs the nation's largest producer of clean, carbon-free energy, Constellation is focused on our purpose: accelerating the transition to a carbon-free future. We have been the leader in clean energy production for more than a decade, and we are cultivating a workplace where our employees can grow, thrive, and contribute. Our culture and employee...

  • Director of Reinsurance Operations

    1 month ago

    Minnesota, United States Neeljym Search Group Full time

    Transform the Future of Mutual InsuranceWe're seeking a visionary leader to join our client's newly formed Insurance Services Platform as the Director of Reinsurance Operations. This is a rare opportunity to shape an entire industry and redefine market standards.Key Responsibilities:Manage reinsurance programs to drive business growth and...

  • Executive Director of Assisted Living

    4 weeks ago

    Hopkins, Minnesota, United States HDG, Inc. Full time

    Purpose of the JobUnder the direction of the Regional Director, the Assisted Living Director leads and directs the overall operation of the assisted living community, ensuring quality care for residents and achieving business and financial profitability. The ideal candidate will possess strong leadership skills, with the ability to engage staff, manage...

  • Executive Director of Assisted Living

    1 month ago

    Hopkins, Minnesota, United States HDG, Inc. Full time

    Purpose of the JobUnder the direction of the Regional Director, the Assisted Living Director leads and directs the overall operation of the assisted living community, ensuring quality care for residents and achieving business and financial profitability. The ideal candidate will possess strong leadership skills, with the ability to engage staff, manage...

  • Advanced Sales Director

    2 weeks ago

    Minnesota, United States Securian Financial Group Full time

    Job Title: Advanced Sales DirectorWe are seeking a highly skilled and experienced Advanced Sales Director to join our team at Securian Financial Group. As a key member of our Individual Solutions market segment, you will be responsible for leading a team of advanced sales professionals and supporting our regional sales directors in the sale of individual...

  • Executive Director

    4 weeks ago

    Minnesota, United States kpCompanies Full time

    Executive Director Opportunity at Healthy Community InitiativekpCompanies is leading the search for a seasoned and community-centric Executive Director for Healthy Community Initiative (HCI). The ideal candidate for this position is a strategic and enterprise-wide thinker, an effective communicator with high integrity and passion for HCI's mission, a...

  • Advanced Sales Director

    2 weeks ago

    Minnesota, United States Securian Financial Group Full time

    Job Title: Advanced Sales DirectorWe are seeking a highly skilled and experienced Advanced Sales Director to join our team at Securian Financial Group. As a key member of our Individual Solutions market segment, you will be responsible for leading a team of advanced sales professionals and supporting our regional sales directors in the sale of individual...