Regulatory Affairs Specialist Job at Hemostasis Corp (Saint Paul)

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
Relevant certifications in Regulatory Affairs are considered a plus
Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong attention to detail, time management and organizational skills
Willingness to learn and ability to work effectively in a team-based environment
Strong communication and interpersonal skills
Proficiency in Microsoft Office Suite and familiarity with document management systems
Fluent in English, both written and spoken

Job Responsibility

Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
Support regulatory strategies by providing impact assessments
Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
Assist colleagues with administrative tasks
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist of Cosmo Intelligent Medical Devices.

Location

Italy , Rome

Salary:

Not provided

Cosmo Intelligent Medical Devices

Expiration Date

Until further notice

Requirements

Bachelor’s degree in medicine, pharmacology, biomedical science or related scientific discipline, or equivalent
Minimum of 5 years of experience in the regulatory affairs field in medical device industry
Minimum of 2 years of experience in vigilance reporting according to 21 CFR Part 803 in U.S and to MDD/MDR requirements in EU
English proficiency at professional level
Deep knowledge and operative understanding of Reg. (EU) 2017/745 and MDCG documents, Title 21 CFR parts 800-898, and technical standards such as ISO 13485, ISO 14971, ISO/TR 20416, ISO 62304
Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy
Basic knowledge of Reg. (EU) 2024/1689
Strong analytical skills with a detail-oriented approach
Ability to work independently and collaboratively across multifunctional teams
Highly dynamic and adaptable to a fast-moving and innovative environment

Job Responsibility

Assess medical device safety by providing input/review to the risk management activities throughout the whole product lifecycle, health hazards evaluations, and clinical evaluation reports
Review and provide input on mitigations, labeling and training materials, adverse events, complaints, incidents, and trends
Manage and document post-marketing safety data, aggregate complaint data, individual case safety reports, literature reports with safety data, trend analysis
Manage vigilance reporting to Competent Authorities and other stakeholders according to country requirements and assess failure investigations from the regulatory viewpoint
Work with customers/users to gather information/data to support investigations and complaints management
Monitor external sources/trends on emerging issues, including complaints, MDR trends, and regulatory trends, literature and scientific publications
Transfer the regulatory compliance aspects during the design and development stage of products and act as contact point across the company functional areas
Act as department representative during audits and other regulatory body interactions in the field of vigilance and post-market surveillance
Cooperate to the management of documented material and communications with Competent Authorities, Certification Bodies, and other stakeholders according to the given regulatory aspect
Cooperate to the management of company regulatory procedures by timely awareness and implementation of changes due to the development in the regulatory landscape

Junior Regulatory Affairs Specialist

Junior Regulatory Affairs Specialist of Cosmo Intelligent Medical Devices.

Location

Italy , Rome

Salary:

Not provided

Cosmo Intelligent Medical Devices

Expiration Date

Until further notice

Requirements

Bachelor’s degree in engineering, science or related scientific discipline, or equivalent
Minimum of 2 years of experience in regulatory affairs roles within the medical devices or healthcare industry
English proficiency at professional level
Professional knowledge of Reg. (EU) 2017/745 and Title 21 CFR parts 800-898 and technical standards ISO 13485, ISO 14971
Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy
Strong analytical skills with a detail-oriented approach
Ability to work independently and collaboratively across multifunctional teams
Highly dynamic and adaptable to a fast-moving and innovative environment

Job Responsibility

Assess, prepare, and manage technical documentation to support certification and submission processes in the European Union and U.S.A
Prepare and manage technical dossiers for submission in other countries according to local regulations and guidance documents
Cooperate with other departments to the creation and update of technical documentation needed according to country requirements
Assist external stakeholders in the regulatory process per country requirements
Maintain and update certifications, registrations, and renewals as required by country regulations and assess regulatory impact of medical device changes with respect to country requirements
Cooperate to the management of documented material and communications with Competent Authorities, Certification Bodies, and other stakeholders according to the given regulatory aspect
Cooperate to the management of company regulatory procedures by timely awareness and implementation of changes due to the development in the regulatory landscape
Assist in internal and external audits and provide regulatory input to optimize company compliance and minimize the possibility of non-compliance findings
Promote the culture of compliance by proactively interacting with all departments and by provision of trainings
Cooperate to the development of new activities, adapt to new challenges and opportunities, and take on new duties stemming from the development path of company activities

Regulatory Specialist

At 2San, we are at the forefront of innovation in the global healthcare industry...

Location

United States , Norwood

Salary:

80000.00 USD / Year

2San

Expiration Date

Until further notice

Requirements

Proven regulatory affairs experience within the healthcare sector, with a focus on Class 2 and Class 3 Self-Test IVDs
Deep understanding of regulatory requirements and processes for the US market, including 510(k) management, FDA submissions, and compliance management
Experience with developing, implementing, and managing Quality Management Systems (QMS) in accordance with US and international standards, including familiarity with ISO 13485
Ability to develop and implement regulatory strategies that align with company objectives and product lifecycle
Strong analytical skills for assessing regulatory compliance, interpreting guidelines, and resolving complex issues
Excellent written and verbal communication skills for effective liaising with regulatory bodies, internal teams, and external partners
Proactive in identifying potential regulatory obstacles and developing effective solutions
Meticulous attention to detail with the capability to manage multiple projects and priorities simultaneously
Bachelor’s degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biomedical Engineering) required
advanced degrees or certifications in regulatory affairs or quality assurance preferred

Job Responsibility

Monitoring and management of new and existing 510(k) entries to ensure all product listings are current and compliant with regulatory requirements
Preparing and submitting FDA applications for new product approvals and amendments for existing products, ensuring all submissions are accurate and meet regulatory standards
Maintaining the regulatory tracker to ensure all information is current and in-line with local requirements
Maintaining regular contact with manufacturers for products supplier in US. Ensuring that their conformity assessment is not due to lapse and ensuring that a plan is in place for updated certification. (IVDD to IVDR)
Regularly reviewing and updating the Quality Management System (QMS) to ensure it aligns with both US and international standards, including ISO 13485, and addressing any gaps or non-compliances
Overseeing Complaints Management and Post-Market Surveillance Activities, including the collection, analysis, and reporting of customer feedback and adverse events to regulatory bodies as required. Implementing corrective actions and ensuring continuous product quality and safety monitoring in compliance with regulatory requirements
Collaborating with product development teams to provide regulatory guidance and support from concept through to commercialization, ensuring regulatory considerations are integrated into product lifecycle management
Navigating regulatory pathways to secure product approval and market entry, including strategizing for efficient and compliant product launches
Applying strong analytical skills to assess regulatory compliance, interpret complex regulatory guidelines, and undertake risk assessments for regulatory strategies and submissions
Proactively identifying potential regulatory challenges and obstacles and working collaboratively with cross-functional teams to develop and implement effective solutions

Regulatory Specialist

Regulatory Specialist (East Windsor, NJ) (Multiple Openings).

Location

United States , East Windsor

Salary:

Not provided

Novitium Pharma

Expiration Date

Until further notice

Requirements

Must have bachelors in Pharmaceutical sciences / biology / microbiology / chemistry / chemical / Regulatory Affairs / Related + 1 year exp. as Regulatory Specialist /Quality Control Analyst / Chemist / Analyst / Scientist/ Research Associate / Related

Job Responsibility

Review, manage and write regulatory submissions electronically which include New ANDA filings, Complete Response letters, Information requests, Amendments to the ANDA’s (Labeling, Chemistry & Bioequivalence) of different dosage forms (Tablet, Capsule, Liquid & Solutions)
responsible for filing the Post Approval Supplements like CBE-0, CBE-30 (Changes being effective in 30 days) and Prior Approval Supplements (PAS)
submitting dossiers electronically after the approval of initial product submissions (ANDA)
review of the leachable and extractable reports generated for the oral Liquid & Solution drug products

Namibia Public Affairs Specialist

You will join the Upstream business unit that develops a competitive and unique ...

Location

Namibia , Windhoek

Salary:

Not provided

Galp

Expiration Date

Until further notice

Requirements

A Namibian National with an established track record of successfully interacting with Namibian Governmental Departments and associated Government Owned Organisations and the wider Namibian general business sector
A passion for the energy industry and understanding of the value chain features, particularly related to upstream exploration and appraisal activity
A humble attitude, the ability to work within a team towards a common goal and be a respected company representative amongst stakeholders to build relationships in multi-cultural environments
Ideally 5+ years of experience in Energy Industry in Namibia or a country with a developed oil and gas sector
Willingness to help local communities and a pronounced social responsibility

Job Responsibility

Develop Galp´s Institutional representation with all relevant stakeholders as well as liase with Government Departments in all related industry issues
Active participation in the shaping of the Oil & Gas public policy environment and ecosystem enabling Galp Namibia to participate and deliver innovative solutions for country regulatory framework
Careful monitor of the changing political dynamics and government policies to identify emerging external challenges and opportunities to Galp, develop recommendations and mitigation actions
Assist in the implementation of the Company Social Responsibility strategy for Namibia
Liaise with Corporate Departments (Finance, Accounting, Tax,Procurement, People Team) to provide local support to any task deemed necessary

What we offer

An energy company integrated in the energy sector where you can make a difference
Challenging Projects
Competitive salary and bonus

Fulltime

Legislative Affairs Specialist III

This is a lobbyist position in the AFSCME Department of Federal Government Affai...

Location

United States , Washington, D.C.

Salary:

102857.00 - 154291.00 USD / Year

American Federation of State, County and Municipal Employees

Expiration Date

Until further notice

Requirements

Graduation from an accredited four-year college with course work in political science, history, or government
Minimum of seven (7) years of related work experience or equivalent combination
Considerable experience in working for labor unions or federal, state or local governments
Considerable experience in oral and written communications including public speaking
Considerable knowledge of the legislative process and the workings of Congress
Thorough knowledge of relevant coalition and support group organizations’ operations
Strong ability to communicate complicated information effectively both orally and in writing
Ability to organize relevant lobbying coalitions
Travel and extended work hours including weekends are required
A valid driver’s license is required

Job Responsibility

Acts as a primary liaison with members of congress, their staff and committees of congress
may appear before congressional committees/groups and travels to state councils to discuss AFSCME’s legislative agenda
Monitors legislative activities, provides analysis and comments on legislation, and advocates for AFSCME’s position on legislation
Develops testimony, letters of support, and other written statements and may serve as AFSCME's spokesperson with members of congress, congressional and agency staff, and interest groups
In consultation with other relevant departments, assists with drafting and revising legislative language
provides briefings on proposed legislation and amendments proposed during legislative sessions
and keeps relevant departments apprised of developments
Serves as a specialist concentrating on major legislative/regulatory issues
In consultation with department leadership, develops grassroots legislative campaign field plans to engage affiliates and coalition partners in campaigns to advance AFSCME’s major legislative priorities
Responds to affiliate and members’ inquiries on a wide variety of legislative and regulatory issues

What we offer

List of benefits

Fulltime

Government Relations Specialist

Corporate Tools is hiring a Government Relations Specialist. You will be a tradi...

Location

United States

Salary:

80000.00 - 90000.00 USD / Year

Corporate Tools

Expiration Date

Until further notice

Requirements

Bachelor's degree (highly preferred)
Strong verbal and written communication skills and ability to adapt communication style to different audiences
At least 2- 4 years of previous, demonstrated experience in a government relations role
Knowledge and understanding of the legislative, regulatory, and policy making processes
An ability to develop and maintain political and key stakeholder relationships
Strong interpersonal skills with the ability to positively interact with diverse political bodies, build relationships, and resolve conflicts diplomatically
Excellent legislative research, writing, research and analysis skills
Ability to travel 25% - 35%, on average, based on the needs of the company

Job Responsibility

Work with Government Relations team to develop and drive advocacy and outreach strategies before federal and state legislative bodies and regulatory agencies on key business issues
Engage policymakers and other policy stakeholders to protect the company’s interests and public policy goals
Collaborate with stakeholders across the company to drive the development of public policy positions
Conduct research and analysis on trending legislative, regulatory, and public policy issues
Assist with building and maintaining relationships with federal and state regulatory agencies and legislative bodies (state legislative bodies, Congress, administration officials)
Contribute to team projects, deliverables, and presentations on a diverse range of legislative and policy topics
Develop briefing materials for internal and external stakeholders on legislative and regulatory issues
Engage with industry associations and third-party coalitions on relevant issues
Travel (35% - 40%) to represent the company before legislative bodies and industry events

What we offer

100% employer-paid medical, dental and vision for employees
Annual review with raise option
22 days Paid Time Off accrued annually, and 4 holidays
After 3 years, PTO increases to 29 days. Employees transition to flexible time off after 5 years with the company—not accrued, not capped, take time off when you want
The 4 holidays are: New Year’s Day, Fourth of July, Thanksgiving, and Christmas Day
Paid Parental Leave
Up to 6% company matching 401(k) with no vesting period
Quarterly allowance
Use to make your remote work set up more comfortable, for continuing education classes, a plant for your desk, coffee for your coworker, a massage for yourself... really, whatever
Open concept office with friendly coworkers

Fulltime

Regulatory Affairs Specialist

Hemostasis Corp

Location:
United States , Saint Paul

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 09, 2025

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