Regulatory Affairs Specialists III

4 days ago

Beachwood, OH, United States Integrated Resources Full time
Job Title: Regulatory Affairs Specialists III
Job Location: Beachwood, OH
Job Duration: 11-12 Months (possibility of extension)
Shift: (days/times) - 1st Shift
Payrate: $48.27/ hr on w2

Essential Responsibilities:
  • Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets.
  • Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc.), product claims and country regulatory dependencies to ensure optimized sequencing for submissions.
  • Works with a cross functional team to prepare and submit regulatory submissions such as 510(k)s, MDR EU Technical Files, or submissions to other global regulators such as NMPA, TGA, etc., for the purpose of obtaining authorization for market launch.
  • Assesses changes in existing products to and determines the need for new / revised licenses or registrations.
  • Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.
  • Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
  • Contributes to writing and editing technical documents.
  • Researches, analyzes, integrates, and organizes background information from diverse sources for regulatory submissions.
  • Ensures compliance with pre- and post-market product approval requirements.
  • Supports regulatory inspections, as required.
Qualifications:
  • Bachelor's degree from an accredited university or college, preferred in a Scientific, Engineering, Regulatory, Legal, or core Life Science discipline.
  • 4+ years' experience in a highly regulated industry, preferred in Regulatory Affairs, or equivalent experience through advanced degree or other relevant education and experience.
  • Strong verbal and written communication, and presentation skills, with the ability to speak and write clearly and convincingly in English.
  • Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and collaboration applications.
Desired Characteristics:
  • Demonstrated ability to analyze and resolve problems.
  • Ability to document, plan, market, and execute programs.
  • Established project management skills.
  • A team player and collaborator.
  • Preferably, Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society (RAPS).
  • Experience in medical device regulatory affairs.
  • Demonstrated life-long learner; eagerness to obtain new skills and knowledge.

  • Regulatory Affairs Specialists III

    7 days ago

    Beachwood, OH, United States Sunrise Systems Full time

    Title: Regulatory Affairs Specialist Job ID: 25-10743 Location: Beachwood, OH (Onsite 3 days/week - local candidates only) Duration: 12 Months on W2 contract| Shift: 1st ShiftOverview: Seeking an experienced Regulatory Affairs Specialist to support product development, regulatory submissions, and compliance for global markets. Responsibilities: Develop and...

  • GEHC - Regulatory Affairs Specialists III

    2 weeks ago

    Beachwood, OH, United States Bayone Full time

    Manager's Note- Candidates must be in the Cleveland area, local to Cleveland, OH because they may have to come into office at 25800 Science Park Dr #180, Beachwood, OH 44122. Title - Regulatory Affairs Specialist Number of Leased Workers needed - 1 Tentative start date - asap Tentative end date - 12 Months Work shift (days/times) - 1st Shift Work Location -...

  • GEHC - Regulatory Affairs Specialists III

    6 days ago

    Beachwood, OH, United States Bayone Full time

    Manager's Note- Candidates must be in the Cleveland area, local to Cleveland, OH because they may have to come into office at 25800 Science Park Dr #180, Beachwood, OH 44122. Title - Regulatory Affairs Specialist Number of Leased Workers needed - 1 Tentative start date - asap Tentative end date - 12 Months Work shift (days/times) - 1st Shift Work Location -...

  • Sales Specialist

    7 days ago

    Beachwood, OH, United States Petco Full time

    Create a healthier, brighter future for pets, pet parents and people! If you want to make a real difference, create an exciting career path, feel welcome to be your whole self and nurture your wellbeing, Petco is the place for you. Our core values capture that spirit as we work to improve lives by doing what's right for pets, people and our planet. We...

  • Sales Specialist

    2 weeks ago

    Beachwood, OH, United States Petco Full time

    Create a healthier, brighter future for pets, pet parents and people! If you want to make a real difference, create an exciting career path, feel welcome to be your whole self and nurture your wellbeing, Petco is the place for you. Our core values capture that spirit as we work to improve lives by doing what's right for pets, people and our planet. We...

  • Senior Manager of Clinical Strategy

    2 weeks ago

    Beachwood, OH, United States Insight Global Full time

    - Clinical Strategy & Protocol Development o Lead the development of IRB and clinical study protocols in alignment with company objectives. o Collaborate with surgeons and clinical advisors to design impactful studies that address business and clinical needs. o Participate in the overall clinical strategy planning process, including statistical analysis...

  • Senior Manager of Clinical Strategy

    6 days ago

    Beachwood, OH, United States Insight Global Full time

    - Clinical Strategy & Protocol Development o Lead the development of IRB and clinical study protocols in alignment with company objectives. o Collaborate with surgeons and clinical advisors to design impactful studies that address business and clinical needs. o Participate in the overall clinical strategy planning process, including statistical analysis...

  • Senior Manager of Clinical Strategy

    1 week ago

    Beachwood, OH, United States Insight Global Full time

    - Clinical Strategy & Protocol Development o Lead the development of IRB and clinical study protocols in alignment with company objectives. o Collaborate with surgeons and clinical advisors to design impactful studies that address business and clinical needs. o Participate in the overall clinical strategy planning process, including statistical analysis...

  • Technical Communication Specialist

    2 weeks ago

    Beachwood, OH, United States MedStar Health Full time

    Tremco Construction Products Group brings together Tremco CPG Inc.'s Commercial Sealants & Waterproofing and Roofing & Building Maintenance divisions; Tremco Barrier Solutions Inc.; Dryvit, Nudura and Willseal brands; Prebuck LLC; Weatherproofing Technologies, Inc.; Weatherproofing Technologies Canada and PureAir Control Services, Inc. Altogether, Tremco CPG...

  • Technical Communication Specialist

    2 weeks ago

    Beachwood, OH, United States MedStar Health Full time

    Tremco Construction Products Group brings together Tremco CPG Inc.'s Commercial Sealants & Waterproofing and Roofing & Building Maintenance divisions; Tremco Barrier Solutions Inc.; Dryvit, Nudura and Willseal brands; Prebuck LLC; Weatherproofing Technologies, Inc.; Weatherproofing Technologies Canada and PureAir Control Services, Inc. Altogether, Tremco CPG...