- Preparing documentation for international regulatory registrations and renewals.
- Defining worldwide regulatory requirements necessary for regulatory approval of assigned products.
- Executing product submission strategies as directed.
- Maintaining all regulatory documentation to ensure availability for external audits and preparation of submission packages.
- Maintaining a thorough knowledge of current regulatory requirements.
- Executing on additional responsibilities as defined by management.
- Bachelor's Degree in Science, Engineering, or other relevant discipline and 4+ years' experience in Regulatory Affairs in the medical device industry.
- Working knowledge of quality system regulations and guidelines.
- Great communication skills with all levels of personnel.
- High level of organization and planning skills.
- Working knowledge of medical devices, procedures, and terminology.
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Regulatory Affairs Specialist III
Found in: Lensa US 4 C2 - 5 days ago
PSG Global Solutions Bridgewater, United StatesWe're looking for a · Regulatory Affairs Specialist III , working in · Pharmaceuticals · and · Medical Products · industry in · Bridgewater, New Jersey, United States . · Contributes to the development and oversees the successful · implementation of regulatory strategies f ...
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USA-Regulatory Affairs Specialist II
Found in: Lensa US 4 C2 - 5 days ago
eTeam Bridgewater, United StatesRegulatory Affairs Specialist II (Clinical) · Bridgewater, NJ-100% Remote · 7 Months contract · Pay Rate: $45-55/hr on w2 · Candidates can be located in any US time zone, they must be able to work EST hours from 9AM-5PM EST Possibility of Extension Role will work independently a ...
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Regulatory Affairs Specialist Team Lead
Found in: Lensa US 4 C2 - 5 days ago
The Fountain Group Bridgewater, United StatesThe Fountain Group are a national staffing firm and are currently seeking a Regulatory Affairs Lead for a prominent Pharmaceutical client of ours. This position is in Bridgewater, NJ (Hybrid Role). Details for the position are as follows: · Job Description: · Pay: /hr on W2. · 9- ...
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USA Regulatory Affairs Specialist Team Lead I Scientific
Found in: Lensa US 4 C2 - 5 days ago
Adecco USA Bridgewater, United StatesAdecco Medical & Science is hiring a contract Regulatory Affairs Team Lead I for our Pharmaceutical partner in Bridgewater, NJ. · The anticipated wage for this position is between $102 and $106 hourly. Hourly wage may depend upon experience, education, geographic location, and o ...
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USA Regulatory Affairs Specialist Team Lead I Scientific
Found in: Lensa US 4 C2 - 5 days ago
Adecco US, Inc. Bridgewater, United StatesAdecco Medical & Science is hiring a contract Regulatory Affairs Team Lead I for our Pharmaceutical partner in Bridgewater, NJ. · The anticipated wage for this position is between $102 and $106 hourly. Hourly wage may depend upon experience, education, geographic location, and ot ...
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Regulatory Affairs Specialist I
Found in: One Red Cent US C2 - 1 week ago
Johnson & Johnson Raynham, United States OTHERDePuy Synthes, part of Johnson & Johnson MedTech, is recruiting for a Regulatory Affairs Specialist I to support our Spine business. This role is located on-site in Raynham, MA and will work a Flex/Hybrid schedule with three days of on-site and two days of off-site work . · Ab ...
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Medical and Clinical Affairs Specialist
Found in: ZipRecruiter Priority US C2 - 3 days ago
Med Device, Biotech and Pharma Consulting Raynham, United StatesJob Description · Job Description A premiere Medical Device company is looking for a Medical/ Clinical Affairs Specialist to assist on a long term contract. · Requirements for the position include: · -Clinical Document Review Experience · -Evidence of Data and Claims · -experienc ...
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Public Affairs Specialist
Found in: beBee S2 US - 3 weeks ago
Department Of Homeland Security Cambridge, United States Full timeSummary · The External Affairs Officer (EXAO) position supervises and directs all aspects of External Affairs components as FEMA supports communities as they recover from disasters. An EXAO is the main point of contact for senior field and Headquarter leaders and is also responsi ...
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Regulatory Affairs Specialist
Found in: Lensa US 4 C2 - 4 days ago
Philips Cambridge, United StatesLooking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all. · **In this role you have the opportunity ...
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Regulatory Affairs Specialist
Found in: Lensa US 4 C2 - 5 days ago
Katalyst Healthcares and Life Sciences Hanscom Air Force Base, United StatesResponsibilities: Prepares regulatory strategies and maintains submissions for U.S. and International markets, including but not limited to 510(k)s and Technical Files, to ensure timely approval of devices and continued regulatory support of marketed devices. · Reviews and summ ...
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Regulatory Affairs Specialist III_US
Found in: Lensa US 4 C2 - 3 days ago
Advanced Clinical Mansfield, United StatesOVERVIEW · We are currently searching for a skilled professional to join a well-known client's team as a Remote Regulatory Affairs Specialist. The Regulatory Affairs Specialist role will independently provide EU regulatory requirements and guidance to EU MDR project teams. Lead ...
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Regulatory Affairs Specialist II
Found in: beBee S2 US - 1 week ago
Johnson & Johnson Raynham, United States OTHERDePuy Synthes, Inc. is currently recruiting for a Regulatory Affairs Specialist II to support Life Cycle Management and New Product Development. This role will work a Hybrid/Flex schedule with 3 days in office each week, located in Raynham, MA or West Chester, PA . · About Joh ...
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Senior Regulatory Affairs Specialist
Found in: Lensa US 4 C2 - 3 days ago
Biofourmis Needham Heights, United StatesThe Senior Regulatory Affairs Specialist will support and carry out the regulatory strategy and other regulatory aspects of product development and processes for the Biofourmis pharma partnerships and DTx algorithms. · Reporting to the SVP of Q&R, the Senior Regulatory Affairs S ...
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Regulatory Affairs Specialist II/Sr
Found in: Lensa US 4 C2 - 5 days ago
Nova Biomedical Waltham, United StatesCareer Opportunities with Nova Biomedical Corporation · Nova Biomedical is an Equal Opportunity Employer in compliance with Affirmative Action in hiring and promoting women, minorities, veterans and individuals with disabilities. · Nova Biomedical is hiring a · Regulatory Affair ...
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Regulatory Affairs Specialist II/Sr
Found in: Lensa US 4 C2 - 3 days ago
Nova Biomedical Watertown, United StatesNova Biomedical is hiring a Regulatory Affairs Specialist (Level II or Senior Level) in our Waltham, MA facility (Hybrid) to focus on assuring company compliance to US 510k, Health Canada Licensing, International Device Submissions, Licensing and Registration requirements, ISO/FD ...
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Regulatory Affairs Operations Specialist, Ad/Promo
Found in: Lensa US 4 C2 - 4 days ago
Ardelyx Waltham, United States· Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA(tenapanor) and XPHOZAH (tenapanor), as well as e ...
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Regulatory Affairs Operations Specialist, Ad/Promo
Found in: Lensa US 4 C2 - 1 day ago
Ardelyx Waltham, United StatesArdelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA(tenapanor) and XPHOZAH (tenapanor), as well as earl ...
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Senior Education and Compliance Specialist, Human Research Affairs
Found in: Jooble US O C2 - 1 day ago
partners Boston, MA, United States: Come join our team and play a pivotal role in promoting and ensuring an environment where human subject research is conducted according to the highest standards · Our Human Research Affairs Compliance and Education Office was established in June 1999 as the Quality Assurance/ ...
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Senior Education and Compliance Specialist, Human Research Affairs
Found in: Jooble US O C2 - 1 day ago
partners Boston, MA, United States: Come join our team and play a pivotal role in promoting and ensuring an environment where human subject research is conducted according to the highest standards · Our Team · Our Human Research Affairs Compliance and Education Office was established in June 1999 as the Quali ...
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Senior Education and Compliance Specialist, Human Research Affairs
Found in: Talent US C2 - 16 hours ago
Partners HealthCare Boston, United States Full timeDescription Come join our team and play a pivotal role in promoting and ensuring an environment where human subject research is conducted according to the highest standards · Our Team · Our Human Research Affairs Compliance and Education Office was established in June 1999 as ...
Senior Regulatory Affairs Specialist - Plymouth, United States - Laborie
Description
We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you.
We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We're not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.
Who We're Looking For:
Laborie Medical Technologies is currently searching for a Senior Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed. The Regulatory Affairs Specialist will perform regulatory submission/approval activities for specific Laborie Medical products and ensures compliance with required regulations and established corporate standards.
How you contribute:
Qualifications:
Why Laborie:
Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.
· Paid time off and paid volunteer time
· Medical, Dental, Vision and Flexible Spending Account
· Health Savings Account with Company Funded Contributions
· 401k Retirement Plan with Company Match
· Parental Leave and Adoption Services
· Health and Wellness Programs and Events
Laborieprovides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.
