Regulatory Affairs, Medical Device

2 weeks ago

Philadelphia, United States NEUROVUE Full time

Expertise Development and Client Engagement:

  • Cultivate and expand expertise in regulatory areas pertaining to Medical Devices, In Vitro Diagnostics (IVD), and/or Software as a Medical Device (SaMD), engaging with potential clients and staying updated on industry trends.
  • Actively participate in client bid defense meetings for prospective projects across the medical device, IVD, and SaMD sectors, providing valuable insights and strategic guidance.

Advisory Consulting Services:

  • Monitor regulatory changes globally and provide proactive advisory services to companies in the medical device, IVD, and/or SaMD sectors, ensuring compliance with new regulations and standards.
  • Offer specialized Subject Matter Expert (SME) consulting on regulatory strategy, submissions, and operational excellence tailored to each sector's unique requirements.

Documentation and Compliance Support:

  • Assist in developing technical documentation and design dossiers to facilitate CE marking, 510(k), or other approval procedures for medical devices, IVDs, and SaMD.
  • Provide SME consulting for regulatory compliance, covering EU Directives, new EU Regulations (MDR & IVDR), FDA requirements, and other relevant regulations applicable to medical devices, IVDs, and SaMD.

Gap Analysis and Process Improvement:

  • Lead comprehensive gap analysis projects for MDR, IVDR, and SaMD regulations, assessing existing systems, processes, and departments against new requirements.
  • Collaborate with stakeholders to identify necessary changes to compliance processes and update associated documentation for each sector.

Risk Management and Quality Assurance:

  • Support the implementation of changes to organizational risk management processes for medical devices, IVDs, and SaMD.
  • Conduct thorough device risk assessments and ensure compliance with ISO 13485, MDSAP, and relevant regulatory standards for each sector.

Technical File Development and Submission Support:

  • Aid in constructing Technical Files according to new MDR & STED format for medical devices, IVDs, and SaMD, including essential requirements evaluation reports, risk management documentation, and clinical evaluation reports.
  • Provide support for regulatory submission projects across medical devices, IVDs, and SaMD, ensuring adherence to market and product-specific requirements.

Client Relationship Management and Project Oversight:

  • Establish and maintain professional relationships with direct and indirect clients in the medical device, IVD, and SaMD sectors, including Health Authorities and Notified Bodies.
  • Take responsibility for operational project planning across all sectors, preparing weekly plans aligned with project timelines and ensuring team members are appropriately trained.

Market Intelligence and Marketing Support:

  • Stay updated on market news and trends across medical devices, IVDs, and SaMD, sharing relevant insights with the team and clients.
  • Support marketing activities such as webinars, blog writing, and participate in presales meetings with prospective clients across all sectors.

Audits and Reporting:

  • Assist in internal and external audits as required, ensuring compliance with regulatory standards for medical devices, IVDs, and/or SaMD.
  • Provide regular status reporting to stakeholders according to an agreed communications plan, encompassing all sectors.

Education & Experience:

  • Bachelor’s Degree in pharmacy, Regulatory Affairs, or relevant Life Sciences fields; Master’s Degree preferred.
  • RAC certification in Medical Devices is advantageous.
  • Minimum 5 years of experience in medical devices, IVDs, or SaMD within industry, consultancy, or regulatory agencies, with expertise in manufacturing, R&D, quality, or regulatory roles.

Skills and Competencies:

  • Technical proficiency in MDD/MDR, IVDR, ISO 13485 standards, and IMDRF requirements across medical devices, IVDs, and/or SaMD.
  • Strong stakeholder management and project management skills applicable to each sector.
  • Excellent written and verbal communication, strategic thinking, and problem-solving abilities.
  • Customer-focused mindset with strong organizational and time management skills, adaptable to diverse regulatory landscapes.

  • Regulatory Affairs, Medical Device

    5 days ago

    Philadelphia, United States NEUROVUE Full time

    Expertise Development and Client Engagement: Cultivate and expand expertise in regulatory areas pertaining to Medical Devices, In Vitro Diagnostics (IVD), and/or Software as a Medical Device (SaMD), engaging with potential clients and staying updated on industry trends. Actively participate in client bid defense meetings for prospective projects across the...

  • Manager, Regulatory Affairs-hybrid

    4 weeks ago

    Philadelphia, United States Adaptimmune Full time

    Job DescriptionJob DescriptionAdaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across...

  • Manager, Regulatory Affairs-hybrid

    2 weeks ago

    Philadelphia, United States Adaptimmune Full time

    Job DescriptionJob DescriptionAdaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across...

  • Regulatory Affairs Specialist, Cell

    6 days ago

    Philadelphia, United States Piper Companies Full time

    Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy Coordinate and manage timing for regulatory submissions,...

  • Regulatory Affairs Specialist, Cell

    1 week ago

    Philadelphia, United States Piper Companies Full time

    Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene TherapyCoordinate and manage timing for regulatory submissions,...

  • Regulatory Affairs Specialist, Cell

    1 week ago

    Philadelphia, United States Piper Companies Full time

    Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy Coordinate and manage timing for regulatory submissions,...

  • Medical Director/Senior Medical Director, Medical Affairs

    2 weeks ago

    Philadelphia, United States Cabaletta Bio Full time

    Medical Director/Senior Medical Director, Medical Affairs Philadelphia, PA About the Position Reporting to the Vice President, Medical Affairs, we are seeking a highly motivated and experienced Medical Director/Senior Medical Director to join our Medical Affairs team. The incumbent will play a crucial role in shaping and executing the medical affairs...

  • Regulatory Affairs Specialist, Cell

    1 week ago

    Philadelphia, PA, United States Piper Companies Full time

    Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies.   Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy Coordinate and manage timing for regulatory...

  • Senior Director, Regulatory Affairs CMC

    1 week ago

    Philadelphia, United States Meet Full time

    Senior Director, Regulatory Affairs CMCHybrid - Philadelphia, PAMeet has partnered with a very well-established pharma with hundreds of approved products. They are looking for a Senior Director of Regulatory CMC (biologics) to join their team. This position will be working across the company's mid-stage, new development pipeline and will be reporting into...

  • Senior Director, Regulatory Affairs CMC

    2 days ago

    Philadelphia, United States Meet Full time

    Senior Director, Regulatory Affairs CMCHybrid - Philadelphia, PAMeet has partnered with a very well-established pharma with hundreds of approved products. They are looking for a Senior Director of Regulatory CMC (biologics) to join their team. This position will be working across the company's mid-stage, new development pipeline and will be reporting into...

  • Regulatory Affairs Specialist, Cell

    1 week ago

    Philadelphia, PA, US Piper Companies Full time

    Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene TherapyCoordinate and manage timing for regulatory submissions,...

  • Regulatory Affairs Specialist, Cell

    1 week ago

    Philadelphia, PA, US Piper Companies Full time

    Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene TherapyCoordinate and manage timing for regulatory submissions,...

  • Associate Director, Cmc Regulatory Affairs

    4 weeks ago

    Philadelphia, United States GSK Full time

    **Site Name**: Durham Blackwell Street, USA - Pennsylvania - Philadelphia **Posted Date**: Apr 17 2024 - Does leading and delivering Chemistry and Manufacturing Controls regulatory strategy interest you? If so, this role may be for you! _ This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities...

  • Regulatory Operations Coordinator

    1 week ago

    Philadelphia, United States Piper Companies Full time

    Piper Companiesis looking for aRegulatory Operations Coordinatorto be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA .Responsibilities for the Regulatory Operations Coordinatorinclude: Work with internal teams and stakeholders to build IND & CTA dossier content plans and...

  • Sr. Regulatory Specialist

    1 week ago

    Philadelphia, United States ZP Group Full time

    Piper Companies is currently looking for an experienced Sr. Regulatory Specialist (IND Submissions) in Philadelphia, Pennsylvania (PA) to work for an innovative and growing biologic oncology pharmaceutical company. The Sr. Regulatory Specialist will play an integral part in the regulatory IND submission process of new pharmaceutical...

  • Regulatory Operations Coordinator

    2 weeks ago

    Philadelphia, United States Piper Companies Full time

    Piper Companies is looking for a Regulatory Operations Coordinator to be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA. Responsibilities for the Regulatory Operations Coordinator include:Work with internal teams and stakeholders to build IND & CTA dossier content...

  • Regulatory Operations Coordinator

    1 week ago

    Philadelphia, PA, United States Piper Companies Full time

    Piper Companies is looking for a  Regulatory Operations Coordinator   to be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA .   Responsibilities for the Regulatory Operations Coordinator   include: Work with internal teams and stakeholders to build IND & CTA...

  • Senior Associate Counsel, Commercial and Regulatory

    1 week ago

    Philadelphia, United States Adaptimmune Therapeutics plc Full time

    Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate...

  • Regulatory Operations Coordinator

    1 week ago

    Philadelphia, PA, US Piper Companies Full time

    Piper Companies is looking for a Regulatory Operations Coordinator to be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA. Responsibilities for the Regulatory Operations Coordinator include:Work with internal teams and stakeholders to build IND & CTA dossier content...

  • Regulatory Operations Coordinator

    1 week ago

    Philadelphia, PA, US Piper Companies Full time

    Piper Companies is looking for a Regulatory Operations Coordinator to be responsible for supporting pre-IND and IND stage regulatory submissions to FDA working for a Biotechnology company in Philadelphia, PA. Responsibilities for the Regulatory Operations Coordinator include:Work with internal teams and stakeholders to build IND & CTA dossier content...