Senior International Regulatory Affairs Specialist
Becton Dickinson & Co
Senior International Regulatory Affairs Specialist at Becton Dickinson responsible for leading medical device regulatory submissions and product registrations across global markets. The role involves managing international approval processes, technical documentation review, cross-functional collaboration, and regulatory strategy development to support market access.
Responsibilities
- Lead collection, compilation, and analysis of country-specific regulatory requirements for device registrations
- Drive international product registrations according to project timelines and business objectives
- Review and approve technical documentation to ensure regulatory submission completeness and accuracy
- Develop regulatory strategies for product registrations, renewals, and lifecycle changes
- Identify regulatory risks, assess business impacts, and escalate critical issues to leadership
Requirements
- Bachelor's degree in health science, life science, biology, chemistry, bio-engineering, microbiology, or related field
- Minimum 6 years medical device industry experience
- International regulatory registration experience across multiple regions (CASAJ, Greater China, LATAM, Canada, EMEA)
- Working knowledge of STED, technical files, design dossiers, and submission structures
- Proficiency with SAP, MasterControl, JDE, and Microsoft Office tools
- Experience navigating Design History Files and reviewing Design Verification reports
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Senior International Regulatory Affairs Specialist in Franklin Lakes, NJ vacancy
$100k - $105k
...Senior Regulatory Affairs Specialist Location: Allendale, NJ, Leesburg, VA, or Remote (10% Travel Required) Company: VB Spine Looking for... ...functional product development teams to ensure US, EU, and international regulatory requirements are incorporated from the...InternationalSeniorWork at officeRemote work$87k - $145.1k
...Flexibility: OnsiteStryker is hiring a Senior CAPA Specialist for the Joint Replacement division in... ...effectiveness and compliance.Support internal, corporate, and external audits and... ...PreferredQualifications:Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.)....InternationalSeniorFull timeFor contractorsStryker
Mahwah, NJ3 days ago- ...Senior Manager overseeing Becton Dickinson's end-to-end U.S. international tax compliance process. Reports to Director of International Tax and manages annual compliance calendar, data collection, complex tax calculations, information returns, external providers, and...InternationalSenior
Becton Dickinson
Franklin Lakes, NJ5 days ago $70k - $85k
...always inspiring more…About the RolePosition SummaryThe Regulatory Affairs Specialist (F&B) will be responsible to independently provide Symrise... ...guidelines, customer specific guidelines, and various international regulations. In addition, this position may support the...InternationalSymrise
Saddle Brook, NJ1 day ago$95.6k - $153k
...The Global Trade Compliance Specialist is responsible for ensuring... ...execution, broker management, regulatory coordination, and trade... ...management while partnering with internal stakeholders, suppliers,... ...Collaborate with Regulatory Affairs and business subject matter...InternationalHourly payDaily paidTemporary workWork at officeWork visaFlexible hoursShift workBecton , Dickinson and Company
Franklin Lakes, NJ5 days ago- ...Senior Accountant Location: Franklin Lakes, NJ Our client is seeking a highly motivated Senior Accountant to join... ...initiatives while partnering with both domestic and international stakeholders. This is an excellent opportunity for an experienced...InternationalSeniorFor contractorsWork at officeLocal area
Vaco
Franklin Lakes, NJ3 days ago $85k - $110k
...Job Description Job Description General Purpose The Senior Buyer is a senior-level Procurement professional responsible for... ...~ Travel approximately 5–10% of the time; domestic and/or international supplier visits may be required. Salary Range: $85,000...InternationalSeniorContract workWork at officeHYTORC
Mahwah, NJa month ago- ...to 40% travel is associated with this position to domestic and international locations.QualificationsA Bachelor's degree in Information... ...Information80-95kSummaryType: Full-timeFunction: Accounting/AuditingExperience level: Mid-Senior LevelIndustry: Staffing And RecruitingInternationalSenior
Clark Davis Associates
Wayne, NJ3 days ago - ...Senior Clinical Data Manager Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected... ...for large projects or multiple smaller projects • Conducts internal and external team meetings, including monthly project review...InternationalSeniorLocal area
Integrated Resources
Woodcliff Lake, NJ4 days ago $150.37k - $255.63k
...Senior Principal RF Engineer BAE Systems is hiring for a Senior Principal RF Engineer. At BAE Systems, we deliver a full range of... ...limited to: business considerations, local market conditions, and internal equity, as well as candidate qualifications, such as skills,...InternationalSeniorFull timeWork experience placementLocal areaBAE Systems USA
Wayne, NJ1 day ago- ...Brimar Industries is seeking an experienced Senior Buyer / Purchasing Agent to join our procurement team. This is a senior, hands... ...managing purchase orders, negotiating with suppliers, coordinating international inbound shipments with freight forwarders and customs brokers,...InternationalSeniorOverseas
Brimar Industries
Garfield, NJ3 days ago $87k - $145.1k
...Senior CAPA Specialist position within the Joint Replacement division's quality management system. The... ...improvement ~ Experience with regulatory agencies (FDA, MoH, TUV) preferred ~ Familiarity with FDA and international medical device quality system standards...InternationalSenior$110.2k - $176.4k
...possibilities. Summary: The Sr. Quality System Specialist is accountable for support of the... .... Working knowledge of quality systems regulatory requirements and application to Company... ...device quality system regulations and international quality system standards/regulations (e...InternationalSeniorHourly payDaily paidTemporary workWork at officeRemote workFlexible hoursShift workBD
Wyckoff, NJ1 day ago- ...Brimar Industries is seeking an experienced Senior Purchasing Agent to join our procurement team. This is a senior, hands-on purchasing... .../replenishment, expediting, and resolving vendor issues. International purchasing/imports: working with overseas suppliers, freight...InternationalSeniorFull timeWork at officeOverseas
Brimar Industries
Garfield, NJ6 hours ago $238k
...career? You just found it.Job OverviewThe Senior Director, Quality & Compliance is... ...compliance with applicable domestic and international regulations while driving operational excellence... ..., continuous improvement, and regulatory compliance throughout the organization....InternationalSeniorWork at officeWorldwideGetinge
Wayne, NJ5 days ago- ...We are seeking a detail-oriented and proactive Senior Accounting Manager to support key accounting operations, including the monthly close, financial reporting, internal controls, audit support, M&A integration activities, and functional oversight of the Accounts Payable...InternationalSeniorFull timeInterim role
Syntagma Group
Montvale, NJ2 days ago - ...Senior Manager Accounting Bergen County, NJ Reporting to: Director Accounting We... ...close process, and support domestic and international audit and compliance requirements while... ...filings and ensure compliance with local regulatory requirements Assist with annual...InternationalSeniorInterim roleLocal area
Sole Solutions
Paramus, NJ5 days ago - ...Senior Marketing Manager Montvale, New Jersey Full Time The Senior Marketing Manager will drive strategic marketing and innovation... .... The individual must combine proven experience in B2B and internal innovation processes, with a strong understanding of the food...InternationalSeniorFull timeShift work
Veracity
Montvale, NJ2 days ago $95k - $120k
...teamwork, and strives for excellence. We are seeking a Senior Accountant to join our growing Finance team at our Teaneck, NJ... ...and responding to auditor requests. Ensure compliance with internal controls, accounting policies, and financial reporting requirements...InternationalSeniorFull timeContract workWork at officeUveye Inc
Teaneck, NJmore than 2 months ago$76k - $96k
...Job Description ■ About the Role \n USA Senior Ocean Operations Specialist is responsible for managing and coordinating end-to-end ocean freight... ...with carriers, customers, customs brokers, and internal teams. The ideal candidate possesses strong ocean freight...InternationalSeniorLX Pantos Americas
Teaneck, NJ6 days ago- ...transformative solutions that turn dreams into possibilities. Summary: The Senior Manager, Program Management and Governance is responsible for... ...to end. Drive a consistent operating cadence across AMER and International workstreams. Lead key decision forums and steering committees,...InternationalSeniorHourly payDaily paidContract workTemporary workLocal areaFlexible hoursShift work
$148.89k
...world. Job Description CDM Smith is currently seeking a Senior Human Resources Business Partner to join our Technical Services... ...will be considered in lieu of a degree. Domestic and/or international travel may be required. The frequency of travel is contingent...InternationalSeniorWork experience placementH1bWork at officeRelocationCDM Smith
Paterson, NJ4 days ago$110.2k - $176.4k
...possibilities. Summary: The Sr. Quality System Specialist is accountable for support of the... .... Working knowledge of quality systems regulatory requirements and application to Company... ...device quality system regulations and international quality system standards/regulations (e...InternationalSeniorHourly payDaily paidTemporary workWork at officeRemote workFlexible hoursShift work$145.05k - $246.58k
...salaries are determined by a variety of factors including, but not limited to: business considerations, local market conditions, and internal equity, as well as candidate qualifications, such as skills, education, and experience. Employee Benefits: At BAE Systems, we...InternationalSeniorFull timeWork experience placementLocal areaBAE Systems USA
Wayne, NJ5 days ago$153.38k - $260.74k
...salaries are determined by a variety of factors including, but not limited to: business considerations, local market conditions, and internal equity, as well as candidate qualifications, such as skills, education, and experience. Employee Benefits: At BAE Systems, we...InternationalSeniorFull timePart timeWork experience placementLocal areaWorldwideBAE Systems
Totowa, NJ2 days ago$105.83k - $179.91k
...the world's most advanced electromagnetic spectrum operations systems - detecting, locating and countering threats for joint and international aircrew. We develop sophisticated digital Electronic Warfare (EW) systems, and we are looking for motivated, positive minded...InternationalSeniorFull timeLocal areaWorldwideFlexible hoursBAE Systems USA
Totowa, NJ1 day ago- ...Senior Systems EngineerPark Ridge, NJ; Jericho, NYAbout GrassiAfter more than 40 years of business growth and industry change, Grassi... ...Island, the Northeast, Florida, New England, Denver and an international presence in Italy, we are strategically positioned to serve clients...InternationalSeniorFixed term contractSummer workWork at officeRemote workFlexible hours
Grassi & Co., CPA's P.C
Park Ridge, NJ2 days ago $150k - $180k
...requirements, support customer, supplier, internal, and third-party audits, and drive... ...and continuous improvement. Safety, Regulatory & Sustainability Support Support regulatory... ...action status, and improvement plans to senior leadership and cross-functional...InternationalSeniorHYTORC
Mahwah, NJ17 days ago$75.4k - $188.6k
...ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections.... ...programs. Work within a global quality organization supporting international clinical research activities. Collaborate with experienced...InternationalSeniorFull timePart timeImmediate startWorldwideIQVIA
Wayne, NJ16 days ago$80k - $110k
Audit Senior - Healthcare & Affordable Housing Park Ridge, NJ About Grassi After more than 40 years of business growth and industry... ...Island, the Northeast, Florida, New England, Denver and an international presence in Italy, we are strategically positioned to serve clients...InternationalSeniorWork at officeLocal areaVisa sponsorshipWork visa
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior International Regulatory Affairs Specialist. Be the first to apply!
Related searches
- senior implementation engineer Franklin Lakes, NJ
- senior medical science liaison Franklin Lakes, NJ
- senior manager m&a tax Franklin Lakes, NJ
- senior application security Franklin Lakes, NJ
- senior manager legal Franklin Lakes, NJ
- senior activities Franklin Lakes, NJ
- senior operations technician Franklin Lakes, NJ
- srs Franklin Lakes, NJ
- senior accountant remote Franklin Lakes, NJ
- senior manager pmo Franklin Lakes, NJ