Regulatory Affairs Specialist II Job at Tucker Parker Smith Group (Irvine)

Group Regulatory Affairs Specialist Class II

At Ontex, we are making everyday life easier across generations. Worldwide our 5...

Location

Germany , Grosspostwitz

Salary:

Not provided

Ontex Peninsular

Expiration Date

Until further notice

Requirements

Master’s degree (university or equal through experience) in science
In-depth knowledge of US and Canada regulations, standards, and guidance documents for medical devices
Minimum of 3 years experience in Regulatory Affairs for medical devices
Experience in 510k submission
Experience or interest in regulatory affairs for Software as Medical Device (SAMD)
Experience in working with cross-functional teams and building strong relationships across departments
Ability to integrate and demonstrate core values, integrity and accountability throughout the organization and externally
Ability to lead, manage, collaborate and communicate within the organization, with groups engaged in the development of good regulatory practice and policy, and within the regulatory profession
Fluent in English

Job Responsibility

Researches and determines requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities
Monitor and evaluate the regulatory environment and provide creative and innovative internal advice throughout the product lifecycle
Supervises data input activities and provides impact analysis and report conclusions and recommendations
Identifies the need for new regulatory procedures and SOPs
Identifies requirements and potential obstacles for market access and distribution
Evaluates proposed preclinical, clinical and manufacturing documents for regulatory filing
Actively contribute in assessing the potential impact of new guidance and regulations on a regulatory filing
Advises stakeholders of regulatory requirements for quality, preclinical and clinical data
Works with cross-functional teams for interactions with regulatory authorities
Provides regulatory information and guidance for proposed product claims/labelling

What we offer

Holiday and Christmas bonuses
30 days of holiday
Company pension scheme
Corporate benefits and discounts

Fulltime

Regulatory Affairs Specialist / Manager (CDx)

Join the SOPHiA GENETICS Global Regulatory Affairs Team as a Regulatory Affairs ...

Location

United States , Boston

Salary:

71000.00 - 168000.00 USD / Year

SOPHiA GENETICS

Expiration Date

Until further notice

Requirements

5-8 years' Regulatory Affairs experience within Diagnostics and/or Medical Devices (complex Class II / Class III)
Practical experience contributing to FDA submissions for diagnostic and/or software medical devices (e.g. Q-Subs, 510(k), De Novo, PMA or supplements), with tangible involvement in drafting or compiling submission content
Background in diagnostics (CDx and/or broader IVD) with an understanding of NGS and/or software as a medical device highly beneficial
Experience interacting with Health Authorities (e.g. FDA) essential
exposure to additional global agencies (e.g. Health Canada, TGA, PMDA or EU Notified Bodies) highly beneficial
Familiarity with global regulatory requirements for diagnostics and an interest in expanding knowledge into new regions and evolving frameworks
Success-orientated and solutions-focused mindset that embraces team collaborations, change, growth and inclusion
Full fluency in English

Job Responsibility

Provide strategic and operational regulatory support for diagnostic and CDx products, including software-based and other complex IVD medical devices
Drive and coordinate the development and execution of US FDA and global regulatory strategies and submission plans (e.g. Q-Subs, 510(k), PMA, and equivalent pathways) to support timely product clearances and approvals
Contribute to the drafting, review, and compilation of regulatory submissions and responses, collaborating closely with clinical, quality, R&D, and commercial teams
Support interactions with regulatory authorities (e.g. FDA and other key agencies) and act as a central point of contact for CDx/IVD regulatory topics across internal stakeholders

What we offer

Outstanding Medical, Dental & Vision with 90% Employer Contribution
Company matched 401K at 4%
Company-paid short & long-term disability insurance
FSA commuter benefits
20 Days PTO, increasing to 25 with tenure
5 Days Sick and 14 Public Holidays
Free EAP

Senior Regulatory Affairs Specialist – Regional

This role offers an exciting opportunity to provide regional regulatory support ...

Location

Malaysia , Petaling Jaya

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in Pharmacy, Science, or equivalent
Minimum 6 years of regulatory experience in the medical devices industry
Strong expertise in new registrations, license extensions, variations, and renewals, with mandatory experience in Class II devices and above
In‑depth knowledge of regulatory laws, acts, and evolving requirements
Solid understanding of GDPMD standards
Skilled in project management, multitasking, and prioritization
Excellent interpersonal, communication, and negotiation skills
Proficiency in technical systems (word processing, spreadsheets, databases, online research)
Ability to identify compliance risks and escalate effectively

Job Responsibility

Develop and execute regulatory project plans that keep products moving efficiently through approval pathways
Identify and escalate regulatory risks early, ensuring proactive solutions
Stay ahead of evolving regulations and translate requirements into clear, actionable steps
Maintain accurate and compliant regulatory files and documentation
Actively contribute to project teams, offering practical regulatory guidance
Respond to inquiries from regulatory authorities within strict timelines
Compile, prepare, and submit new registrations, variations, renewals, and change notifications to secure timely approvals
Review and approve labeling and promotional materials to ensure compliance with local regulations
Represent Regulatory Affairs in project teams, supporting business objectives and compliance standards
Manage post‑market surveillance (PMS), field actions, and complaints in Singapore and Malaysia

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

New

Associate Regulatory Specialist II

Ecolab is seeking to hire an Associate Regulatory Specialist II/Engineer located...

Location

Poland , Kraków

Salary:

Not provided

Edgerton Dental Clinic

Expiration Date

Until further notice

Requirements

Bachelor’s degree in electrical/Electronics/Industrial/Mechanical or Telecommunication Engineering
2+ years of professional work experience working at a certification agency, testing lab or coordinating regulatory approvals
Able to clearly explain project status and hurdles
Experience in navigating cross functional teams to obtain results
Comfortable to perform administrative tasks like documentation collection, organizing files, and creating record documents
Project management experience
Familiar with extracting information from SAP, Excel, and Power Point
Used to work in virtual environment like Microsoft Teams and lead virtual meetings in English
Fluency in English

Job Responsibility

Lead and coordinate efforts to ensure equipment satisfies appropriate testing standards mandatory for placing in the market
Obtain Drinking Water Directive and local Drinking Water Approvals
Create and maintain equipment technical files documenting equipment regulatory compliance meeting Machine Regulation requirements
Support Packaging & Packaging Waste Regulation (PPWR) by identifying requirements through building technical files
Define equipment in scope for WEEE and report of sales data to the authorities
Collect compliance documentation from suppliers (Reach, RoHS, EU DoC, Drinking Water)
Will work in close collaboration with larger EU Team to complete projects across all divisions
Organize laboratories and product certification agencies for testing equipment

What we offer

Competitive Compensation: Attractive salary (Base pay & Variable Plan) and benefits package (private medical care, life insurance, stock purchase, lunch subsidy, sport cards)
Work-Life Balance: Flexible working arrangements with hybrid model of work (approx. 60% from the office and 40% from home)
Matrix Organization: Thrive in our matrix organization, working across Europe with various teams and cultural backgrounds
Collaborative Environment: Strong teamwork and diverse interactions
Development Opportunities: Personalized plans with rapid progression
Versatile Career Paths: Professional growth supported by active committee for different career levels
Supportive Culture: High employee satisfaction and responsive feedback
Learning and Innovation: Continuous learning and technical training incl. subject matter experts’ trainings, soft skills and management trainings and LinkedIn learning
Relocation Support: Assistance for international candidates and candidates living outside of Krakow
Social events such as family events and charity auctions

Fulltime

New

Senior Regulatory Writer

CK QLS is currently recruiting for a Senior Regulatory Writer to join a leading ...

Location

Switzerland , Allschwil

Salary:

110.00 - 150.00 CHF / Hour

CK Group

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences (Master's degree preferred)
Minimum of 5 years' experience in regulatory or medical writing within the pharmaceutical industry
Strong knowledge of regulatory guidelines and document requirements
Demonstrated ability to produce high-quality clinical and regulatory documentation
Experience across multiple therapeutic areas is advantageous
Excellent written and verbal communication skills in English
Ability to work independently, manage competing priorities, and meet deadlines

Job Responsibility

Author and review clinical regulatory documents, including CTD Module II summaries, Clinical Overviews, and Clinical Study Reports (CSRs)
Prepare responses to health authority questions, briefing documents, safety updates, and investigator brochures
Provide scientific and strategic input to submission and study teams
Contribute to the planning and presentation of data analyses and review statistical documentation
Collaborate with cross-functional stakeholders, including Clinical Sciences, Biometry, Drug Safety, and Regulatory Affairs
Work with documentation specialists to ensure timely and high-quality deliverables
Support the selection and management of external regulatory writing vendors
Mentor and support junior writers

Fulltime

New

Pharmacy Technician

We’re building a world of health around every individual — shaping a more connec...

Location

United States , Drexel Hill

Salary:

Not provided

CVS Health

Expiration Date

June 22, 2026

Requirements

Must comply with any state board of pharmacy requirements or laws governing the practice of pharmacy, which includes but is not limited to, age, education, and licensure/certification
If the state board of pharmacy does not address or mandate a minimum age requirement, must be at least 16 years of age
If the state board of pharmacy does not address or mandate a minimum educational requirement, must have a high school diploma or equivalent, or be actively enrolled in high school or high school equivalency program
State-level licensure and national certification requirements vary by state, click here to learn more
Regular and predictable attendance, including nights and weekends
Ability to complete required training within designated timeframe
Attention and Focus
Customer Service and Team Orientation
Communication Skills
Mathematical Reasoning

Job Responsibility

Living our purpose by following all company SOPs at each workstation to help our Pharmacists manage and improve patient health
Following pharmacy workflow procedures at each pharmacy workstation (i.e., production, pick-up, drive-thru, and drop-off) for safe and accurate prescription fulfillment
Contributing to positive patient experiences by showing empathy and genuine care
Completing basic inventory activities, as permitted by law, and as directed by the pharmacy leadership team
Contributing to a high-performing team, embracing a growth mindset, and being receptive to feedback
Remaining flexible for both scheduling and business needs, while contributing to a safe, inclusive, and engaging team dynamic
Understanding and complying with all relevant federal, state, and local laws, regulations, professional standards, and ethical principles
Delivering additional patient health care services (e.g., immunizations, point-of-care testing, and voluntarily staffing offsite clinics), where allowable by law and supported by required training and certification
Where permissible, the Pharmacy Technician may also support immunizations, which includes the following responsibilities: Completing additional licensure and training requirements, in compliance with state Board of Pharmacy regulations, to obtain Technician Immunizer status to support preparing and administering vaccines
Educating patients about the importance of vaccines and referring patients to the Pharmacist-on-duty for vaccination questions

What we offer

medical, dental, and vision coverage
paid time off
retirement savings options
wellness programs
and other resources, based on eligibility

Fulltime

New

Mri Technologist

MedPro Healthcare Staffing, a Joint Commission-certified staffing agency, is see...

Location

United States , Springfield

Salary:

Not provided

MedPro Healthcare Staffing

Expiration Date

Until further notice

Requirements

Completion of a two year approved School of Radiologic Technology
Valid state radiology registration as required by state law
Registry by the American Registry of Radiologic Technology.

Job Responsibility

MRI technologists utilize their knowledge of anatomy, physiology and the principles of MRI to safely and efficiently operate MRI scanners, assisting in the diagnosis of disease and injury.
Ensure the safety of patients, staff and visitors who come in contact with the powerful magnetic field of a MRI scanner.
Position patients and coils on a table that slides inside the MRI scanner.
Inject contrast media as required.
Set appropriate technical parameters, operate MRI scanners and related equipment, and observe image data on computer monitors during scans.
Be familiar with the differences from a normal image and an abnormal image.
Recognize and respond to life threatening situations.
Assure compliance with federal, state, and local technical and professional regulations and accepted practiced guidelines.
Delivers quality, cost effective patient care in a professional manner.
Works effectively to maintain an environment of excellence, which is patient focused, providing timely, compassionate, quality patient care.

What we offer

Weekly pay and direct deposit
Full coverage of all credentialing fees
Private housing or housing allowance
Group Health insurance for you and your family
Company-paid life and disability insurance
Travel reimbursement
401(k) matching
Unlimited Referral Bonuses up to $1,000

Fulltime

New

Pharmacy Technician

We're building a world of health around every individual — shaping a more connec...

Location

United States , Oakville

Salary:

18.94 - 28.94 USD / Hour

CVS Health

Expiration Date

June 23, 2026

Requirements

Must be at least 16 years of age
Licensure requirements vary by state
Attention and Focus
Customer Service Orientation
Communication Skills
Mathematical Reasoning
Problem Resolution
Physical Demands
Visual Acuity
High School diploma or equivalent preferred but not required.

Job Responsibility

manage all assigned pharmacy workstations and tasks to support the team's ability to promptly, safely and accurately fill patient prescriptions
provide caring service that exceeds customer expectations

What we offer

dental
vision
wellness resources
employee discounts
access to certain voluntary benefits

Parttime

Regulatory Affairs Specialist II

Tucker Parker Smith Group

Location:
United States , Irvine

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 21, 2026

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