Regulatory Affairs Director jobs in Oklahoma City, OK

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Regulatory Affairs Specialist I
  • DiaSorin
  • Stillwater, OK FULL_TIME
  • Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.

    Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

    Why Join Diasorin?

    Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

    Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

    Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.

    Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.

    Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

    Job Scope:
    Developing Regulatory Specialist with a background in science, skilled communicator, and quick learner. Specialist works as an important part of the team to learn regulatory requirements of all countries and to submit applications for registrations. Demonstrated progression will lead to more types of submissions, regulatory activities, and responsibilities. May hold position as lead for an activity such as labeling, international submissions, etc.

    Key Responsibilities and Duties

    Follow procedures to maintain compliance with regulations, standards and guidance's.

    Assist cross-functional teams with regulatory information such as licenses, listings, and classifications.

    Create, revise, review, and maintain regulatory compliance for labels and IFUs.

    Use a variety of systems to complete tasks and maintain records.

    Provide international STED submissions and requested declarations and other documentation to

    subsidiaries/distributors to obtain and maintain registrations.

    Update European/international technical files as needed when there are changes to products, testing,

    manufacturing, claims, file requirements or labeling.

    Be accountable in maintaining quality work and supporting a work environment of continuous improvement to

    increase efficiency, quality and compliance.

    Participate in training and education seminars to grow regulatory knowledge.

    Submit Canadian license applications and amendments.

    Assist with other duties as opportunities arise.

    QUALIFICATIONS

    Bachelor's Degree in life science or engineering and 1-5 years experience in the field.

    Experience in IVD device company

    Detail-oriented, level-headed team player that can work well with others to accomplish goals.

    Demonstrated skills in communications, both written and verbal, including detail to spelling and grammar.

    Ability to navigate new systems and become readily proficient

    Acts responsibly to lead the company toward regulatory compliance and voice concerns.

    Willingness to learn and grow as an individual, as part of a department and a company

    Monitor and track regulatory changes and communicate potential impact to relevant departments.

    Continuously evaluate and improve regulatory processes and procedures.

    Represent the company in external meetings and conferences related to regulatory affairs.

    Adhere to all company policies, procedures, and ethical standards.

    What we offer

    Receive a competitive salary and benefits package as you grow your career at Diasorin. Join our team and discover how your work can impact the lives of people all over the world.

    Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

    In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

    Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation.

    The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.

    Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

    Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.

    This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.
  • 7 Days Ago

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Regulatory Affairs Specialist I
  • DiaSorin
  • Stillwater, OK FULL_TIME
  • Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 yea...
  • 7 Days Ago

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Legislative Liaison/Sr Policy Director
  • Oklahoma Office of Juvenile Affairs
  • Oklahoma, OK FULL_TIME
  • CompensationLegislative Liaison/Sr Policy Director - Commensurate with experienceTitleLegislative Liaison & Sr. Policy AnalystSalaryCommensurate with experience Minimum QualificationsA Bachelors degre...
  • 6 Days Ago

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Director of Government and Public Affairs
  • Rausch Coleman Development Group Inc.
  • Oklahoma, OK FULL_TIME
  • DescriptionImproving quality of life, one home at a time.At Rausch Coleman Homes, we honor God through our commitment to Integrity and Excellence in all aspects of homebuilding. We place the highest v...
  • 28 Days Ago

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Director of Development and Unit Lead for Student Affairs
  • OSU Foundation
  • Stillwater, OK FULL_TIME
  • VISION: Transform the university through the power of generosity.MISSION: Unite donor passions with university priorities to elevate the impact of Oklahoma State University.DEPARTMENT PURPOSE: Raise p...
  • 6 Days Ago

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Director of Development and Unit Lead for Student Affairs
  • Oklahoma State University Foundation
  • Stillwater, OK FULL_TIME
  • VISION: Transform the university through the power of generosity. MISSION: Unite donor passions with university priorities to elevate the impact of Oklahoma State University. DEPARTMENT PURPOSE: Raise...
  • 8 Days Ago

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0 Regulatory Affairs Director jobs found in Oklahoma City, OK area

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Chief Executive Officer - Make-A-Wish® Oklahoma
  • Sagency
  • Oklahoma City, OK
  • About Make-A-Wish® Oklahoma For children diagnosed with critical illnesses, a wish come true can be a crucial turning po...
  • 5/4/2024 12:00:00 AM

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Lead and Copper Regional Lead-Charlotte,NC
  • Black & Veatch
  • Oklahoma City, OK
  • **Lead and Copper Regional Lead-Charlotte,NC** Date: Apr 25, 2024 Location: Charlotte, TX, US US Company: Black & Veatch...
  • 5/4/2024 12:00:00 AM

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Night Operation Supervisor; Sunday - Thursday
  • McKesson Corporation
  • Oklahoma City, OK
  • McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for del...
  • 5/4/2024 12:00:00 AM

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Director Adult Central Sterile Processing
  • OU Health
  • Oklahoma City, OK
  • General Description: The Enterprise Director, Sterile Processing is responsible for the direction and leadership of oper...
  • 5/4/2024 12:00:00 AM

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Workforce Development Coordinator
  • Metro Technology Centers
  • Oklahoma City, OK
  • Additional Information: Show/Hide Job Title: Workforce Development Coordinator Salary Structure: $61,870.04+/yr Position...
  • 5/4/2024 12:00:00 AM

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RN Bariatric Program Manager - Bariatric Surgery Clinic
  • OU Health
  • Oklahoma City, OK
  • Position Title: RN Bariatric Program Manager - Bariatric Surgery Clinic Department: OUHP Bariatric Surgery Clinic Job De...
  • 5/3/2024 12:00:00 AM

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Manager Case Management Utilization Review - OU Medical Center
  • OU Health
  • Oklahoma City, OK
  • Position Title: Manager Case Management Utilization Review - OU Medical Center Department: Case Management Job Descripti...
  • 5/3/2024 12:00:00 AM

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Director of Operations (September 2023 Requisition)
  • Progentec Diagnostics, Inc.
  • Oklahoma City, OK
  • Company Description About us Progentec Diagnostics, Inc. is a biotech company that combines cutting-edge laboratory test...
  • 5/1/2024 12:00:00 AM

Oklahoma City lies along one of the primary corridors into Texas and Mexico, and is a three-hour drive from the Dallas-Fort Worth metroplex. The city is in the Frontier Country region in the center of the state, making it an ideal location for state government. According to the United States Census Bureau, the city has a total area of 620.34 square miles (1,606.7 km2), of which 601.11 square miles (1,556.9 km2) is land and 19.23 square miles (49.8 km2) is water. Oklahoma City lies in the Sandstone Hills region of Oklahoma, known for hills of 250 to 400 feet (120 m) and two species of oak: blac...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$154,717 to $220,353
Oklahoma City, Oklahoma area prices
were up 1.2% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020