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Regulatory Affairs Specialist at Sasmar Pharmaceuticals
Tasmania, Tasmania, Australia - Full Time
Skills Needed
Regulatory Affairs, Life Sciences, Communication Skills, Medical Devices
Specialization
Relevant Field
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Graduate - Regulatory Affairs at Merck Sharp & Dohme Corp. /Netherlands
London, England, United Kingdom - Full Time
Skills Needed
Regulatory Affairs, Communication, Teamwork, Initiative, Proactivity, Academic Curiosity, Integrity, Transparency, Accountability, Diversity, Inclusivity, Regulatory Strategy, Regulatory Compliance, Life Cycle Maintenance, Health Authority Interactions, Operational Excellence
Specialization
Candidates should have a degree in relevant fields such as Pharmacy, Chemical Engineering, or Biology. The program is open to students based in the UK who complete their undergraduate degree between 2024 and 2026.
Sr Manager Regulatory Affairs at Dexcom
San Diego, California, United States - Full Time
Skills Needed
Regulatory Affairs, Samd Regulations, Fda Guidance, Iso Standards, Technical Documentation, Team Management, Digital Health Products, Cybersecurity, Data Privacy, Software Development, Ai/Ml Technologies, Agile Methodologies, Change Management, Product Classification, Regulatory Submissions, Quality Assurance
Specialization
Candidates typically require a Bachelor’s degree and 13+ years of relevant experience in the medical device industry, including 5-8 years of people management experience. A minimum of 5 years of regulatory affairs experience is also required.
Experience Required
Minimum 10 year(s)
Regulatory Affairs Specialist at OrganOx
Oxford, England, United Kingdom - Full Time
Skills Needed
Management System, Regulatory Affairs, Regulatory Submissions, Organization Skills, Documentation, Microsoft Word, Excel, Maintenance
Qualification
Graduate
Regulatory Affairs Specialist at BioLase
Corona, CA 92880, USA - Full Time
Skills Needed
Regulatory Affairs, Iso, Life Sciences, Communication Skills
Specialization
Life sciences engineering or a related field
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Regulatory Affairs Associate at Career Connections Canada Inc
Mississauga, ON, Canada - Full Time
Skills Needed
Regulatory Affairs, Computer Skills, Communication Skills, Dental Care, Adobe Acrobat, Harmonization, It, Analytical Skills, Chemistry
Qualification
BSc
Experience Required
Minimum 5 year(s)
Regulatory Affairs Specialist at Asahi Intecc USA Inc
Irvine, CA 92614, USA - Full Time
Skills Needed
Medical Devices, Powerpoint, Excel, Interpersonal Skills, Communication Skills
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Student Affairs Administrator at McGill University
Montréal, QC, Canada - Full Time
Skills Needed
Good Communication Skills
Specialization
Operations
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Academic Affairs Coordinator at The University of Texas at Tyler
Tyler, Texas, USA - Full Time
Skills Needed
Critical Thinking, Analytical Skills, Learners, Interpersonal Skills, Regulatory Requirements, Platforms
Specialization
Administration, Business, Management
Qualification
Graduate
REGULATORY AFFAIRS ASSOCIATE at AbbVie
Montréal, QC, Canada - Full Time
Skills Needed
Microbiology, Chemistry, Regulations, English, Working Environment, Disabilities, Toxicology, Pharmaceutical Industry, Medical Devices, Pharmacology, Biology, Regulatory Submissions, Regulatory Affairs, Small Molecules, Filing, Biochemistry, Biologics, Life Sciences
Specialization
Biochemistry biology microbiology chemistry
Qualification
MSc
Experience Required
Minimum 1 year(s)
Regulatory Affairs Specialist at Sunco Foods Inc
Burnaby, BC, Canada - Full Time
Skills Needed
Food Science, Documentation, Regulatory Agencies, Secondary Education, Cfia, Food Safety, Packaging, Dental Care, Microbiology, Regulatory Affairs
Specialization
Food science regulatory affairs microbiology or a related discipline
Qualification
Diploma
Experience Required
Minimum 5 year(s)
Associate, Regulatory Affairs at ClinChoice
Yerevan, , Armenia - Full Time
Skills Needed
Regulatory Submission, Product Registration, Teamwork, Pressure Management, Label Creation, Quality Check
Specialization
A Bachelor’s Degree in Life Science is required, with experience in the related field being a plus. Fluency in English and the ability to work under pressure are essential.
Regulatory Affairs Specialist at Dexcom
San Diego, California, United States - Full Time
Skills Needed
Regulatory Affairs, Medical Device, Software Development, Technical Documentation, Cross Functional Collaboration, Risk Assessment, Fda Regulations, Iso Standards, Agile Methodologies, Digital Health, Ai Technologies, Mobile Development, Cloud Based Solutions, Change Assessment, Validation Activities, Product Labeling
Specialization
Candidates should have experience in medical device design and development processes, along with knowledge of relevant regulations and standards. Excellent writing and communication skills are essential, as well as experience in a cross-functional environment.
Experience Required
Minimum 2 year(s)
Graduate Affairs Assistant II at Western University
London, ON, Canada - Full Time
Skills Needed
Confidentiality, Analytical Skills, Service Orientation, Owl, Conditional Formatting, Discretion, Spreadsheets, Databases, Outlook, Pivot Tables, Sensitive Information, Adobe Acrobat, Announcements, Communication Skills, Microsoft Office, Excel
Specialization
Administration
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Regulatory Affairs Specialist at Innovative Health LLC
Scottsdale, AZ 85257, USA - Full Time
Skills Needed
Regulatory Requirements, Powerpoint, Excel, Software, Minitab, Iso Standards
Specialization
Technical field (i.e
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Regulatory Affairs Associate at Career Connections Canada Inc
Montréal, QC, Canada - Full Time
Skills Needed
Adobe Acrobat, It, Dental Care, Communication Skills, Computer Skills, Analytical Skills, Chemistry, Harmonization, Regulatory Affairs
Qualification
BSc
Experience Required
Minimum 5 year(s)
Regulatory Affairs Executive at CorDx
Singapore, , Singapore - Full Time
Skills Needed
Regulatory Affairs, Product Registration, Medical Devices, Iso13485, Clinical Research, Project Management, Communication, Data Collection, Collaboration, Problem Solving, Quality Management, In Vitro Diagnostic Products, Performance Evaluation, Presentation Skills, Team Player, Attention To Detail
Specialization
Candidates should have a bachelor's degree in Life Sciences, Pharmacy, or a related field, and be familiar with medical device laws and regulations. Experience with Class B, C, and D medical devices and in vitro diagnostic products is essential.
Experience Required
Minimum 2 year(s)
Public Affairs Community Lead at Roche
Welwyn, England, United Kingdom - Full Time
Skills Needed
Government Officials, Public Affairs
Qualification
Graduate
Regulatory Affairs Specialist at Getinge Ltd
Derby, England, United Kingdom - Full Time
Skills Needed
Iso, Post Market Surveillance, Multi National Teams, Regulatory Affairs, Life Sciences
Specialization
Engineering
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Regulatory Affairs Specialist at Retractable Technologies
Little Elm, Texas, USA - Full Time
Skills Needed
Microsoft Word, Microsoft Excel, Mdr, Regulatory Submissions, English, Regulatory Affairs
Specialization
Prepare and maintain domestic and international regulatory registrations device registrations listings certifications export certificates and declarations of conformity.
Qualification
Trade Certificate
Experience Required
Minimum 3 year(s)
Regulatory Affairs Specialist at Sasmar Pharmaceuticals
Tasmania, Tasmania, Australia -
Full Time

Start Date

Immediate

Expiry Date

11 Nov, 25

Salary

0.0

Posted On

11 Aug, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Affairs, Life Sciences, Communication Skills, Medical Devices

Industry

Pharmaceuticals

Description

DESCRIPTION

SASMAR is actively seeking a dedicated and detail-oriented Regulatory Affairs Specialist to join our Regulatory department. As a leading pharmaceutical company specializing in personal care and fertility products, including the acclaimed Conceive Plus brand, we have established a strong presence in over 70 countries. Our commitment to innovation and quality ensures that our products are available through various channels, from supermarkets and pharmacies to clinics and hospitals.
In the role of Regulatory Affairs Specialist, you will be instrumental in ensuring our products meet all necessary regulatory requirements for various global markets. This includes preparing and submitting essential regulatory documents, managing product registrations, and keeping abreast of evolving regulatory landscapes.

REQUIREMENTS

  • Bachelor’s degree in a relevant field, such as life sciences or pharmacy.
  • Minimum 2 years of experience in regulatory affairs, preferably in the pharmaceutical or personal care industry.
  • In-depth knowledge of Medical Devices, Food Supplement regulations and requirements.
  • Experience with 9001 / 13485 quality inspections and compliance audits.
  • Strong understanding of cGMPs and REACH regulations.
  • Proficient in writing Standard Operating Procedures (SOPs).
  • Excellent written and verbal communication skills.
  • Strong analytical and problem-solving skills with the ability to manage multiple projects.
  • Ability to work independently and as part of a collaborative team.
Responsibilities
  • Prepare and submit regulatory documents including product registration dossiers and variations.
  • Ensure compliance with international regulatory guidelines from agencies such as FDA, EMA, AFMPS, and TGA.
  • Provide regulatory guidance and training to ensure adherence to regulations across all markets.
  • Maintain accurate records and manage data entries into WERC’s, generating Safety Data Sheets (SDS) as required.
  • Review and interpret regulations to develop compliant strategies for ingredients, packaging, and finished products.
  • Collaborate with cross-functional teams to support product development and quality assurance initiatives.
  • Monitor the status of regulatory submissions and provide updates as needed.
  • Stay informed on regulatory changes and industry best practices.
  • Participate in regulatory inspections and audits.
  • Maintain and update regulatory documentation and databases.
Regulatory Affairs Specialist at Sasmar Pharmaceuticals
Tasmania, Tasmania, Australia - Full Time
Skills Needed
Regulatory Affairs, Life Sciences, Communication Skills, Medical Devices
Specialization
Relevant Field
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Graduate - Regulatory Affairs at Merck Sharp & Dohme Corp. /Netherlands
London, England, United Kingdom - Full Time
Skills Needed
Regulatory Affairs, Communication, Teamwork, Initiative, Proactivity, Academic Curiosity, Integrity, Transparency, Accountability, Diversity, Inclusivity, Regulatory Strategy, Regulatory Compliance, Life Cycle Maintenance, Health Authority Interactions, Operational Excellence
Specialization
Candidates should have a degree in relevant fields such as Pharmacy, Chemical Engineering, or Biology. The program is open to students based in the UK who complete their undergraduate degree between 2024 and 2026.
Sr Manager Regulatory Affairs at Dexcom
San Diego, California, United States - Full Time
Skills Needed
Regulatory Affairs, Samd Regulations, Fda Guidance, Iso Standards, Technical Documentation, Team Management, Digital Health Products, Cybersecurity, Data Privacy, Software Development, Ai/Ml Technologies, Agile Methodologies, Change Management, Product Classification, Regulatory Submissions, Quality Assurance
Specialization
Candidates typically require a Bachelor’s degree and 13+ years of relevant experience in the medical device industry, including 5-8 years of people management experience. A minimum of 5 years of regulatory affairs experience is also required.
Experience Required
Minimum 10 year(s)
Regulatory Affairs Specialist at OrganOx
Oxford, England, United Kingdom - Full Time
Skills Needed
Management System, Regulatory Affairs, Regulatory Submissions, Organization Skills, Documentation, Microsoft Word, Excel, Maintenance
Qualification
Graduate
Regulatory Affairs Specialist at BioLase
Corona, CA 92880, USA - Full Time
Skills Needed
Regulatory Affairs, Iso, Life Sciences, Communication Skills
Specialization
Life sciences engineering or a related field
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Regulatory Affairs Associate at Career Connections Canada Inc
Mississauga, ON, Canada - Full Time
Skills Needed
Regulatory Affairs, Computer Skills, Communication Skills, Dental Care, Adobe Acrobat, Harmonization, It, Analytical Skills, Chemistry
Qualification
BSc
Experience Required
Minimum 5 year(s)
Regulatory Affairs Specialist at Asahi Intecc USA Inc
Irvine, CA 92614, USA - Full Time
Skills Needed
Medical Devices, Powerpoint, Excel, Interpersonal Skills, Communication Skills
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Student Affairs Administrator at McGill University
Montréal, QC, Canada - Full Time
Skills Needed
Good Communication Skills
Specialization
Operations
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Academic Affairs Coordinator at The University of Texas at Tyler
Tyler, Texas, USA - Full Time
Skills Needed
Critical Thinking, Analytical Skills, Learners, Interpersonal Skills, Regulatory Requirements, Platforms
Specialization
Administration, Business, Management
Qualification
Graduate
REGULATORY AFFAIRS ASSOCIATE at AbbVie
Montréal, QC, Canada - Full Time
Skills Needed
Microbiology, Chemistry, Regulations, English, Working Environment, Disabilities, Toxicology, Pharmaceutical Industry, Medical Devices, Pharmacology, Biology, Regulatory Submissions, Regulatory Affairs, Small Molecules, Filing, Biochemistry, Biologics, Life Sciences
Specialization
Biochemistry biology microbiology chemistry
Qualification
MSc
Experience Required
Minimum 1 year(s)
Regulatory Affairs Specialist at Sunco Foods Inc
Burnaby, BC, Canada - Full Time
Skills Needed
Food Science, Documentation, Regulatory Agencies, Secondary Education, Cfia, Food Safety, Packaging, Dental Care, Microbiology, Regulatory Affairs
Specialization
Food science regulatory affairs microbiology or a related discipline
Qualification
Diploma
Experience Required
Minimum 5 year(s)
Associate, Regulatory Affairs at ClinChoice
Yerevan, , Armenia - Full Time
Skills Needed
Regulatory Submission, Product Registration, Teamwork, Pressure Management, Label Creation, Quality Check
Specialization
A Bachelor’s Degree in Life Science is required, with experience in the related field being a plus. Fluency in English and the ability to work under pressure are essential.
Regulatory Affairs Specialist at Dexcom
San Diego, California, United States - Full Time
Skills Needed
Regulatory Affairs, Medical Device, Software Development, Technical Documentation, Cross Functional Collaboration, Risk Assessment, Fda Regulations, Iso Standards, Agile Methodologies, Digital Health, Ai Technologies, Mobile Development, Cloud Based Solutions, Change Assessment, Validation Activities, Product Labeling
Specialization
Candidates should have experience in medical device design and development processes, along with knowledge of relevant regulations and standards. Excellent writing and communication skills are essential, as well as experience in a cross-functional environment.
Experience Required
Minimum 2 year(s)
Graduate Affairs Assistant II at Western University
London, ON, Canada - Full Time
Skills Needed
Confidentiality, Analytical Skills, Service Orientation, Owl, Conditional Formatting, Discretion, Spreadsheets, Databases, Outlook, Pivot Tables, Sensitive Information, Adobe Acrobat, Announcements, Communication Skills, Microsoft Office, Excel
Specialization
Administration
Qualification
Graduate
Experience Required
Minimum 3 year(s)
Regulatory Affairs Specialist at Innovative Health LLC
Scottsdale, AZ 85257, USA - Full Time
Skills Needed
Regulatory Requirements, Powerpoint, Excel, Software, Minitab, Iso Standards
Specialization
Technical field (i.e
Qualification
Graduate
Experience Required
Minimum 5 year(s)
Regulatory Affairs Associate at Career Connections Canada Inc
Montréal, QC, Canada - Full Time
Skills Needed
Adobe Acrobat, It, Dental Care, Communication Skills, Computer Skills, Analytical Skills, Chemistry, Harmonization, Regulatory Affairs
Qualification
BSc
Experience Required
Minimum 5 year(s)
Regulatory Affairs Executive at CorDx
Singapore, , Singapore - Full Time
Skills Needed
Regulatory Affairs, Product Registration, Medical Devices, Iso13485, Clinical Research, Project Management, Communication, Data Collection, Collaboration, Problem Solving, Quality Management, In Vitro Diagnostic Products, Performance Evaluation, Presentation Skills, Team Player, Attention To Detail
Specialization
Candidates should have a bachelor's degree in Life Sciences, Pharmacy, or a related field, and be familiar with medical device laws and regulations. Experience with Class B, C, and D medical devices and in vitro diagnostic products is essential.
Experience Required
Minimum 2 year(s)
Public Affairs Community Lead at Roche
Welwyn, England, United Kingdom - Full Time
Skills Needed
Government Officials, Public Affairs
Qualification
Graduate
Regulatory Affairs Specialist at Getinge Ltd
Derby, England, United Kingdom - Full Time
Skills Needed
Iso, Post Market Surveillance, Multi National Teams, Regulatory Affairs, Life Sciences
Specialization
Engineering
Qualification
Graduate
Experience Required
Minimum 2 year(s)
Regulatory Affairs Specialist at Retractable Technologies
Little Elm, Texas, USA - Full Time
Skills Needed
Microsoft Word, Microsoft Excel, Mdr, Regulatory Submissions, English, Regulatory Affairs
Specialization
Prepare and maintain domestic and international regulatory registrations device registrations listings certifications export certificates and declarations of conformity.
Qualification
Trade Certificate
Experience Required
Minimum 3 year(s)