The ideal candidate will have strong experience with FDA regulatory frameworks, hands‐on expertise in eCTD/dossier preparation, and familiarity with regulatory information management systems such ...
The ideal candidate will have strong experience with FDA regulatory frameworks, hands‐on expertise in eCTD/dossier preparation, and familiarity with regulatory information management systems such ...
The ideal candidate will assess and enhance regulatory processes, focusing on PMTA and SE application submissions per FDA requirements. Responsibilities include conducting assessments, developing ...
The ideal candidate will assess and enhance regulatory processes, focusing on PMTA and SE application submissions per FDA requirements. Responsibilities include conducting assessments, developing ...
Respond to FDA queries and requests in a timely and accurate manner to maintain project momentum. * Collaborate with cross-functional teams to ensure regulatory compliance in launch preparation ...
Respond to FDA queries and requests in a timely and accurate manner to maintain project momentum. * Collaborate with cross-functional teams to ensure regulatory compliance in launch preparation ...
Respond to FDA queries and requests in a timely and accurate manner to maintain project momentum. * Collaborate with cross-functional teams to ensure regulatory compliance in launch preparation ...
Respond to FDA queries and requests in a timely and accurate manner to maintain project momentum. * Collaborate with cross-functional teams to ensure regulatory compliance in launch preparation ...
Respond to FDA queries and requests in a timely and accurate manner to maintain project momentum. * Collaborate with cross-functional teams to ensure regulatory compliance in launch preparation ...
Respond to FDA queries and requests in a timely and accurate manner to maintain project momentum. * Collaborate with cross-functional teams to ensure regulatory compliance in launch preparation ...
Respond to FDA queries and requests in a timely and accurate manner to maintain project momentum. * Collaborate with cross-functional teams to ensure regulatory compliance in launch preparation ...
Respond to FDA queries and requests in a timely and accurate manner to maintain project momentum. * Collaborate with cross-functional teams to ensure regulatory compliance in launch preparation ...
Respond to FDA queries and requests in a timely and accurate manner to maintain project momentum. * Collaborate with cross-functional teams to ensure regulatory compliance in launch preparation ...
Respond to FDA queries and requests in a timely and accurate manner to maintain project momentum. * Collaborate with cross-functional teams to ensure regulatory compliance in launch preparation ...
Food and Drug Administration (FDA), EU notified bodies and worldwide product registrations. This ... S. and EU regulatory strategies and prepare submissions for Class II medical devices. • Create ...
Food and Drug Administration (FDA), EU notified bodies and worldwide product registrations. This ... S. and EU regulatory strategies and prepare submissions for Class II medical devices. • Create ...
Food and Drug Administration (FDA), EU notified bodies and worldwide product registrations. This ... S. and EU regulatory strategies and prepare submissions for Class II medical devices. Create ...
Food and Drug Administration (FDA), EU notified bodies and worldwide product registrations. This ... S. and EU regulatory strategies and prepare submissions for Class II medical devices. Create ...
Food and Drug Administration (FDA), EU notified bodies and worldwide product registrations. This ... S. and EU regulatory strategies and prepare submissions for Class II medical devices. ● Create ...
Food and Drug Administration (FDA), EU notified bodies and worldwide product registrations. This ... S. and EU regulatory strategies and prepare submissions for Class II medical devices. ● Create ...
Regulatory & Clinical Specialist
Minneapolis, MN · Remote
$85K - $95K/yr
Maintains a continued awareness and understanding of EU and FDA regulations and guidance documents. * Prepare regulatory submissions assigned (510(k); IDE & IDE Supplements; PMA Supplements ...
Regulatory & Clinical Specialist
Minneapolis, MN · Remote
$85K - $95K/yr
Maintains a continued awareness and understanding of EU and FDA regulations and guidance documents. * Prepare regulatory submissions assigned (510(k); IDE & IDE Supplements; PMA Supplements ...
Regulatory Compliance Specialist
Saint Paul, MN · On-site
$30 - $37/hr
Follow FDA regulations, company policies, and QMS requirements. * Collaborate professionally with internal teams and external partners. * Perform other related duties and responsibilities as assigned.
Regulatory Compliance Specialist
Saint Paul, MN · On-site
$30 - $37/hr
Follow FDA regulations, company policies, and QMS requirements. * Collaborate professionally with internal teams and external partners. * Perform other related duties and responsibilities as assigned.
Regulatory Compliance Specialist
Saint Paul, MN · On-site
$30 - $37/hr
Follow FDA regulations, company policies, and QMS requirements. * Collaborate professionally with internal teams and external partners. * Perform other related duties and responsibilities as assigned.
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Regulatory Compliance Specialist
Saint Paul, MN · On-site
$30 - $37/hr
Follow FDA regulations, company policies, and QMS requirements. * Collaborate professionally with internal teams and external partners. * Perform other related duties and responsibilities as assigned.
May interface directly with FDA and other regulatory agencies if so directed. * Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS ...
May interface directly with FDA and other regulatory agencies if so directed. * Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS ...
May interface directly with FDA and other regulatory agencies if so directed. * Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS ...
May interface directly with FDA and other regulatory agencies if so directed. * Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS ...
May interface directly with FDA and other regulatory agencies if so directed. * Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS ...
May interface directly with FDA and other regulatory agencies if so directed. * Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS ...
May interface directly with FDA and other regulatory agencies if so directed. * Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS ...
May interface directly with FDA and other regulatory agencies if so directed. * Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS ...
Regulatory Affairs Specialist
Minneapolis, MN · On-site +1
$110.18K - $120K/yr
Prepare and/or review US FDA 510(k) regulatory submissions and 510(k) letters to file to obtain/maintain U.S. market clearance. * Prepare and/or review technical documentation for Health Canada and ...
Regulatory Affairs Specialist
Minneapolis, MN · On-site +1
$110.18K - $120K/yr
Prepare and/or review US FDA 510(k) regulatory submissions and 510(k) letters to file to obtain/maintain U.S. market clearance. * Prepare and/or review technical documentation for Health Canada and ...
Regulatory Affairs Specialist
Fridley, MN · On-site
$110.18K - $120K/yr
Prepare and/or review US FDA 510(k) regulatory submissions and 510(k) letters to file to obtain/maintain U.S. market clearance. * Prepare and/or review technical documentation for Health Canada and ...
Regulatory Affairs Specialist
Fridley, MN · On-site
$110.18K - $120K/yr
Prepare and/or review US FDA 510(k) regulatory submissions and 510(k) letters to file to obtain/maintain U.S. market clearance. * Prepare and/or review technical documentation for Health Canada and ...
Ensure adherence to FDA regulations, global regulatory requirements, company policies, and internal procedures. * Maintain effective communication and collaboration with internal stakeholders ...
Ensure adherence to FDA regulations, global regulatory requirements, company policies, and internal procedures. * Maintain effective communication and collaboration with internal stakeholders ...
Fda Regulatory information
See Minnesota salary details
$18.60 - $22.47
3% of jobs
$22.47 - $26.35
6% of jobs
$26.35 - $30.22
13% of jobs
$30.73 is the 25th percentile. Wages below this are outliers.
$30.22 - $34.10
20% of jobs
The median wage is $35.60 / hr.
$34.10 - $37.97
19% of jobs
$37.97 - $41.84
9% of jobs
$43.78 is the 75th percentile. Wages above this are outliers.
$41.84 - $45.72
10% of jobs
$45.72 - $49.59
6% of jobs
$49.59 - $53.47
5% of jobs
$53.47 - $57.34
5% of jobs
$57.34 - $61.21
3% of jobs
$18
$38
$61
How much do fda regulatory jobs pay per hour?
As of May 28, 2026, the average hourly pay for fda regulatory in Minnesota is $38.76, according to ZipRecruiter salary data. Most workers in this role earn between $31.06 and $45.91 per hour, depending on experience, location, and employer.
What is an FDA Regulatory job?
An FDA Regulatory job involves ensuring that products such as pharmaceuticals, medical devices, and biologics comply with U.S. Food and Drug Administration (FDA) regulations. Professionals in this field prepare and submit regulatory documents, monitor compliance with changing laws, and help companies navigate the approval process. They work closely with internal teams and regulatory agencies to ensure safety, efficacy, and legal adherence.
What are the key skills and qualifications needed to thrive in the Fda Regulatory position, and why are they important?
To thrive in an FDA Regulatory role, you must have a thorough understanding of FDA regulations, submission requirements, and scientific or technical documentation, usually supported by a degree in life sciences or a related field. Proficiency with regulatory submission software (such as eCTD), knowledge of guidance documents, and sometimes RAC certification are highly valued. Strong organizational abilities, problem-solving skills, and clear communication are essential soft skills for coordinating between internal teams and external agencies. These qualifications are vital to ensure compliance, successful product approvals, and effective interaction with regulatory authorities.
What are the main responsibilities of someone working in an FDA Regulatory position?
Professionals in FDA Regulatory roles are primarily responsible for preparing, reviewing, and submitting documents to the FDA to support the approval of pharmaceuticals, medical devices, or other regulated products. You will monitor regulatory changes, ensure company practices comply with relevant laws, and serve as a liaison between your organization and the FDA. Daily tasks often involve cross-functional collaboration with research, quality assurance, and product development teams. This role is both fast-paced and detail-oriented, requiring you to manage multiple projects and adapt to evolving regulatory landscapes.
More about Fda Regulatory jobs
What are popular job titles related to Fda Regulatory jobs in Minnesota? For Fda Regulatory jobs in Minnesota, the most frequently searched job titles are:
What job categories do people searching Fda Regulatory jobs in Minnesota look for? The top searched job categories for Fda Regulatory jobs in Minnesota are:
- Regulatory Affairs Food Supplements
- Freelance Biotech Regulatory Affairs
- Entry Level Regulatory Affairs
- Raps Regulatory Affairs
- Regulatory Affairs Manager
- Volunteer Pharmaceutical Regulatory Affairs
- Remote Veterinary Regulatory Affairs
- Regulatory Affairs Associate
- Assistant Regulatory Affairs Cosmetics
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Full-time
This job post has expired today. Applications are no longer accepted.
Job description
Technical Recruiter @ Calculated Hire | Ethical Advertising, Communication Regulatory Affairs Analyst Remote 1-YR Contract (possibility of extension) Virginia, USA Overview: Our client is seeking a Regulatory Affairs Specialist to assess and enhance regulatory affairs processes, focusing on the preparation and submission of PMTA and SE applications in compliance with FDA requirements. In this role, you will conduct current state assessments, develop detailed process flow documentation, identify gaps or inefficiencies, and recommend modernization initiatives. You will collaborate closely with cross-functional teams to ensure alignment with regulatory standards and modernization goals.
The ideal candidate will have strong experience with FDA regulatory frameworks, hands‐on expertise in eCTD/dossier preparation, and familiarity with regulatory information management systems such as Veeva RIM. Excellent analytical, communication, and stakeholder engagement skills are essential for success in this position. Responsibilities: Conduct current state assessments of regulatory affairs processes and workflows with key stakeholders.
Develop detailed process flow documentation and identify gaps or inefficiencies. Analyze opportunity areas and provide recommendations for modernization initiatives. Support preparation and submission of PMTA and SE applications in compliance with FDA requirements.
Collaborate with cross-functional teams to ensure alignment with regulatory standards and modernization goals. Qualifications: Proven experience in regulatory affairs, including PMTA and SE application processes. Strong knowledge of FDA regulatory frameworks and compliance requirements.
Hands‐on experience with eCTD/dossier preparation and submission. Familiarity with Veeva RIM or similar regulatory information management systems. Excellent analytical, communication, and stakeholder engagement skills.
Flexible remote work environment Opportunity to drive modernization initiatives in regulatory affairs Collaborative and cross‐functional team culture Competitive hourly compensation Seniority Level Associate Employment Type Full-time Job Function Legal and Research Industries Legal Services and Tobacco Manufacturing #J-18808-Ljbffr
About Calculated Hire
Sourced by ZipRecruiter
Industry
Recruiting and staffing services
Company size
51 - 200 Employees
Headquarters location
Indianapolis, IN, US
Year founded
2015