Senior Regulatory Affairs Specialist

1 month ago

Mahwah, United States Stryker Full time

Work Flexibility: Hybrid

We are currently seeking a Senior Regulatory Affairs Specialist to join our Joint Replacement Division based hybrid two days per week in Mahwah, NJ.

Who we want

  • Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
What you will do

As the Senior Regulatory Affairs Specialist, you will evaluate the regulatory environment providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance. You will assist in the development of regulatory strategy and update strategy based upon regulatory changes.
  • Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
  • Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
  • Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
  • Evaluates proposed products for regulatory classification and jurisdiction
  • Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
  • Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
  • Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
  • Negotiates with regulatory authorities throughout the product lifecycle
  • Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
  • Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
  • Assists other departments in the development of SOPs to ensure regulatory compliance
  • Provides regulatory input and technical guidance on global regulatory requirements to product development teams
  • Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
  • Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
  • Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
  • Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
  • Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
  • Provides regulatory information and guidance for proposed product claims/labeling
  • Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
  • Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
  • Monitors the progress of the regulatory authority review process through appropriate communications with the agency
  • Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
  • Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
What you need
  • Bachelor's Degree required; engineering or science degree is preferred.
  • 2+ years of experience in an FDA regulated industry required; preferably within medical devices.
  • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
  • Medical device regulatory experience preferred.
  • General understanding of product development process and design control.
  • General understanding of regulations applicable to the conduct of clinical trials.
  • Familiarity with FDA, Europe and international medical device regulations.


Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

  • Regulatory Affairs Specialist

    4 days ago

    Mahwah, United States Actalent Full time

    Job Title: Regulatory Affairs SpecialistJob Description As a Regulatory Affairs Specialist, your role will be to coordinate, prepare, and review regulatory documents/certifications required for both domestic and international projects. This includes Specification Sheets, Safety Data Sheets (SDS), Flavor/Fragrance Allergens, GMO, Organic, Natural, IFRA,...

  • Regulatory Affairs Specialist

    6 days ago

    Mahwah, United States Lucta Full time

    Summary To ensure that all Flavor, Fragrance & feed formulations comply with industry, Federal/State, Global/International Regulatory bodies and customer requirements. To function as a liaison with internal departments (i.e. QA, Customer/Project Service, R&D, etc.) regarding the exchange and coordination of information required by our customers. Interface...

  • Regulatory Affairs Specialist

    1 week ago

    Mahwah, United States Lucta Full time

    Summary To ensure that all Flavor, Fragrance & feed formulations comply with industry, Federal/State, Global/International Regulatory bodies and customer requirements. To function as a liaison with internal departments (i.e. QA, Customer/Project Service, R&D, etc.) regarding the exchange and coordination of information required by our customers. Interface...

  • Regulatory Affairs Specialist

    2 weeks ago

    Mahwah, United States FLAVOR & FRAGRANCE Full time

    Job DescriptionJob DescriptionSummary To ensure that all Flavor, Fragrance & feed formulations comply with industry, Federal/State, Global/International Regulatory bodies and customer requirements. To function as a liaison with internal departments (i.e. QA, Customer/Project Service, R&D, etc.) regarding the exchange and coordination of information required...

  • Regulatory Affairs Specialist

    1 week ago

    Mahwah, United States Lucta Full time

    Summary To ensure that all Flavor, Fragrance & feed formulations comply with industry, Federal/State, Global/International Regulatory bodies and customer requirements. To function as a liaison with internal departments (i.e. QA, Customer/Project Service, R&D, etc.) regarding the exchange and coordination of information required by our customers. Interface...

  • Regulatory Affairs Specialist

    3 weeks ago

    Mahwah, United States FLAVOR & FRAGRANCE Full time

    Job DescriptionJob DescriptionSummary To ensure that all Flavor, Fragrance & feed formulations comply with industry, Federal/State, Global/International Regulatory bodies and customer requirements. To function as a liaison with internal departments (i.e. QA, Customer/Project Service, R&D, etc.) regarding the exchange and coordination of information required...

  • Regulatory Affairs Specialist

    5 days ago

    Mahwah, United States Lucta Full time

    Summary To ensure that all Flavor, Fragrance & feed formulations comply with industry, Federal/State, Global/International Regulatory bodies and customer requirements. To function as a liaison with internal departments (i.e. QA, Customer/Project Service, R&D, etc.) regarding the exchange and coordination of information required by our customers. Interface...

  • Senior Staff Regulatory Compliance Specialist

    3 weeks ago

    Mahwah, United States Stryker Full time

    Why RA/QA at Stryker?Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working...

  • Regulatory Compliance Specialist- MDR Vigilance

    3 weeks ago

    Mahwah, United States System One Full time

    Job Title: Regulatory Compliance Specialist- MDR Vigilance Location: Mahwah, NJ (Remote) Hours/Schedule: 8am- 5pm Type: contract Overview Leading Medical Device company looking for an experienced Regulatory Compliance Specialist. Ideal candidates should have experience with regulatory compliance, Post-Market adverse event reporting with biotechnology or...

  • Senior Compliance Manager- GQO and Corporate Functions

    1 month ago

    Mahwah, United States Stryker Corporation Full time

    Why join Stryker? We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com Who you are: * Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases,...

  • Senior Compliance Manager- GQO and Corporate Functions

    4 weeks ago

    Mahwah, United States Stryker Corporation Full time

    Why join Stryker? We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com Who you are: * Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases,...

  • Senior Mechanical Engineer, R&D

    2 weeks ago

    Mahwah, New Jersey, United States Stryker Full time

    Work Flexibility: Hybrid or Onsite Stryker is seeking to hire a Senior Mechanical Engineer to support Stryker's Biomechanics team in Joint Replacement. This role is hybrid, and located in Mahwah, NJ. Stryker | Joint Replacement WHO WE WANT: Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing...

  • Senior Accountant

    1 week ago

    Mahwah, United States The Axel Group, LLC Full time

    Our client is a leading organization in the manufacturing sector, committed to delivering high-quality products and services. We are currently seeking a highly skilled and experienced Senior Accountant to join our clients dynamic team. If you are passionate about accounting and have a knack for innovation and process improvement, we would love to hear from...

  • Senior Accountant

    1 week ago

    Mahwah, United States The Axel Group, LLC Full time

    Our client is a leading organization in the manufacturing sector, committed to delivering high-quality products and services. We are currently seeking a highly skilled and experienced Senior Accountant to join our clients dynamic team. If you are passionate about accounting and have a knack for innovation and process improvement, we would love to hear from...

  • Senior Mechanical Engineer, R&D

    1 month ago

    Mahwah, United States Stryker Full time

    Why engineering at Stryker?At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly...

  • Senior Mechanical Engineer, R&D

    4 weeks ago

    Mahwah, United States Stryker Full time

    Why engineering at Stryker?At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly...

  • UIS Regional Manager, Ultrasound

    1 month ago

    Mahwah, United States Mindray North America Full time

    Job DescriptionJob DescriptionRegional Sales Manager Ultrasound/Midwest Region Job Summary: The Regional Sales Manager (RSM) is responsible for recruiting, developing and managing the mid-western territory Ultrasound Sales as well as help to drive direct sales in hospitals and surgery centers and maximizing revenue growth for the US Ultrasound Imaging...

  • UIS Regional Manager, Ultrasound

    4 weeks ago

    Mahwah, United States Mindray North America Full time

    Job DescriptionJob DescriptionRegional Sales Manager Ultrasound/Midwest Region Job Summary: The Regional Sales Manager (RSM) is responsible for recruiting, developing and managing the mid-western territory Ultrasound Sales as well as help to drive direct sales in hospitals and surgery centers and maximizing revenue growth for the US Ultrasound Imaging...

  • Senior Project Engineer

    2 weeks ago

    Mahwah, New Jersey, United States Stryker Full time

    The Senior project engineer will support an engineering team to deliver key programs or projects per associated timelines, quality requirements, and budget within Stryker's Craniomaxillofacial business unit. This is a hybrid role located in Mahwah, NJ. This a dual role with project management and engineering responsibilities.Who We Want:Collaborative...

  • Nobelprocera Services Clinical Specialist

    3 weeks ago

    Mahwah, United States Nobel Biocare Full time

    Operating Company: Nobel Biocare Location: Mahwah,NJ,US Date Posted: April 19, 2024 Req Number: R5019372 The NobelProcera Clinical Specialist has advanced knowledge in evaluating complex dental prosthetic cases, in addition to less complex cases. The Clinical Specialist oversees cases as they move through each step of the process to ensure that details are...