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
Knowledge of quality management systems and medical device standards such as ISO 13485, ISO 14971
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

Job Responsibility

Researches and determines requirements for regulatory submissions, approval pathways and compliance activities
Monitor and evaluate the regulatory environment and provide internal advice
Supervises data input activities and provides impact analysis
Identifies the need for new regulatory procedures and SOPs
Identifies requirements for market access and distribution
Evaluates proposed preclinical, clinical and manufacturing documents for regulatory filing
Actively contribute in assessing the impact of new guidance and regulations
Provides regulatory input and technical guidance on global regulatory requirements
Advises stakeholders of regulatory requirements for quality, preclinical and clinical data
Works with cross-functional teams for interactions with regulatory authorities

What we offer

Permanent employment contract in a future-proof company bound by collective agreements
Attractive remuneration and comprehensive social benefits
Holiday and Christmas bonuses
30 days of holiday
Company pension scheme
Corporate benefits and discounts
Exciting and varied working environment

Fulltime

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

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

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

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

Global Regulatory Specialist

As a Global Regulatory Specialist, you will join our Quality & Regulatory Affair...

Location

Sweden , Stockholm

Salary:

Not provided

Tobii Dynavox

Expiration Date

Until further notice

Requirements

A bachelor’s degree in Regulatory Affairs, Life Sciences, Electrical-Electronics or a related field
At least 5 years of experience in medical device regulatory affairs with hands-on experience with EU MDR (Class I) and FDA QSR
Experience with regulatory systems, document control tools, and QMS platforms and exposure to technical documentation, internal and external audits for regulatory compliance
Strong organization, coordination and communication skills to engage auditors and communicating with stakeholders across functions and levels
Ability to break down complex regulatory topics clearly for both technical and non-technical stakeholders
Proficiency in both spoken and written communication in English

Job Responsibility

Streamline regulatory processes and set a roadmap in collaboration Product & Development, QA, and Operations teams
Coordinate with internal and external auditors to support audit readiness
Review device classifications and regulatory challenges across markets
Maintain and update technical documentation (Annex II & III) and declarations of conformity, including EU Declaration of Conformity, in alignment with the associated technical documentation
Coordinate establishment of registrations and device listings with the FDA, Authorized Representatives, and Importers/Distributors
Support product registrations and market access activities (EU MDR Class I, FDA 510(k)-exempt Class II)
Monitor regulatory changes and communicate implications to relevant teams

Fulltime

Lead Medical Writer

Our client is a global healthcare services and products company providing pharma...

Location

United States , Dublin

Salary:

80.00 - 95.00 USD / Hour

Medasource

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (PhD, PharmD, MD, or MS preferred)
5+ years of regulatory/medical writing experience in the pharmaceutical industry across several therapeutic areas
Proven ability to autonomously write and review clinical regulatory documents (e.g., CTD Module II summaries, CSRs, Clinical Overviews, Investigator brochures, and other regulatory submissions)
Strong knowledge of regulatory document requirements and guidelines
Experience contributing scientifically and strategically to submission teams
Ability to plan data analyses and review statistical analysis plans for CSRs
Excellent collaboration skills with cross-functional stakeholders
Well-developed medical writing skills with attention to quality and deadlines
Ability to mentor and develop junior medical writers
Ability to work independently and as part of a team

Job Responsibility

Autonomously write and review clinical regulatory documents, including CTD Module II summaries, Clinical Overviews, Clinical Study Reports (CSRs), and other regulatory submissions such as responses to health authority questions, briefing books, 120-day safety updates, pediatric investigational plans, and investigator brochures
Contribute scientifically and strategically to submission teams at the project and/or study team level, providing input on pooling strategy, content expertise, and guidance on regulatory requirements
Plan and review data analyses and presentations for CSRs
review statistical analysis plans and related documents
Collaborate effectively with cross-functional stakeholders, including Clinical Sciences, Clinical Pharmacology, Biometry, Drug Safety, Clinical Operations, CMC, and Regulatory Affairs
Work with in-house Documentation Specialists to produce high-quality final documents and ensure timely delivery
Mentor and develop junior medical writers, providing guidance and support as needed
Demonstrate advanced medical writing skills and maintain up-to-date knowledge of regulatory document requirements and guidelines
Work independently and as part of a team, managing multiple priorities and meeting challenging deadlines
Exhibit excellent interpersonal and presentation skills in all interactions

What we offer

Medical coverage
Dental coverage
Vision coverage
Health Savings Account
Dependent Care FSA
Supplemental coverage
401k plan with company match
Paid time off
Sick time
Paid company holidays

Fulltime

New

Sales Development Representative

As a Sales Development Representative, you will manage both inbound & outbound l...

Location

Australia , North Sydney

Salary:

70000.00 - 90000.00 AUD / Year

Workday

Expiration Date

Until further notice

Requirements

2+ years proven track record of achieving & exceeding sales targets in a inbound and / or outbound BDR role
You don't wait for permission to act. Whether you've led sports teams, held leadership roles in academia, or initiated movements, we want to hear from those who instinctively lead from the front
You are self-motivated, driven, and hungry for success. Whether it's in sales, sports, or any endeavor, your commitment to learning, growing, and achieving is paramount
You excel at building relationships quickly and aren't shy about connecting with others
Our core values are the foundation of our culture, guiding our daily interactions and motivating high performance with mutual respect and unwavering trust

Job Responsibility

Manage both inbound & outbound leads
Play a key role in driving our sales pipeline by identifying, qualifying, and delivering qualified opportunities to our Account Executives across ANZ
Work closely with our regional marketing teams to execute campaigns and provide valuable feedback
Collaborate with Account Executives to develop effective account engagement strategies
Generate high-value activity
Conduct in-depth research to understand industry drivers
Communicate professionally with C-Suite executives to articulate the value of our solutions

What we offer

High Earning Potential
Clear Career Pathways
Industry-Leading Mentorship
Comprehensive Benefits
Continuous Learning
Competitive Compensation
Collaborative Culture
Diverse and Supportive Team

Fulltime

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Regulatory Affairs Specialist II

Job Description

Job Responsibility

Requirements

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