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Tampa, Florida, Biotech Research Group is a scientific and regulatory consulting firm located in Tampa, Florida, position can be remote. Our firm serves clients around the globe in the pharmaceutical, biologics and medical device industries. We have an opening on our team for someone who can primarily provide regulatory submission services to our clients both in the medical device and pharmaceutical arenas. The ideal candidate will have expertise in a multitude of regulatory submission types, including pharmaceuticals with a strong background in the medical device industry.   Summary of Position: You have the opportunity, to join Biotech Research Group as a Regulatory Expert and be part of a talented and dynamic team. In this important and exciting role, you will be responsible for executing US regulatory submissions for our medical device and pharmaceutical clients. Reporting directly to the VP of Regulatory Affairs, you will partner closely with other BRG team members.  If you are a RAPS professional who is looking to work remote or work in Tampa, this could be the perfect opportunity for you!   Specific Job Responsibilities: Act as a team player– someone who is positive, forward-looking, accountable, action-oriented, and focused on delivering results Provide expertise to develop and implement complex regulatory strategies throughout the product lifecycle that are consistent with goals and objectives Prepare and review FDA submissions and other regulatory documents including Pre-Subs, 510(k)s, Special 510(k)s, PMAs, PMA Supplements, PMA Amendments, De Novo, Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE), Humanitarian Use Device (HUD) Applications, MDRs, and various annual, periodic, and/or study reports Strategize and develop regulatory plans and documents for products, product updates, manufacturing process changes, marketing materials, and clinical trials Assess and review client’s medical device files for regulatory requirements mainly for US and European markets Utilize knowledge of regulatory requirements applying to manufacturers’ processes and products Review product design, documenting any deficiencies, review engineering and manufacturing Create reports for clients utilizing analytical skills, technical knowledge and excellent written communication skills Respond to inquiries immediately  Acquire new accounts Work with minimal supervision while obtaining project objectives Possible travel depending on project Supports product recall and removal planning, execution, and tracking Maintains current knowledge of FDA medical device regulations and guidances Assist with FDA submissions for Pre-IND, IND, ANDA, OTC, DMF Required Knowledge, Skills, and Abilities: Minimum Master's scientific-related degree required (doctorate preferred) Minimum of 10 years of experience with Medical Device industry and directly working with and being responsible for Regulatory Affairs/Submissions to FDA (additionally, EU submissions helpful) Thorough knowledge and demonstrated ability to successfully submit documents related to Pre-Subs, 510(k)s, Special 510(k)s, PMAs, and De Novo requests Knowledge of engineering and technical applications used in the development of medical devices is helpful Excellent interpersonal, verbal, written and presentation skills.  Must work well in project teams Strong analytical skills while handling multiple projects, delivering results on time using well developed problem-solving skills Pro-active attitude and excellent organizational skills and the ability to work autonomously Experience with FDA submissions for Pre-IND, IND, ANDA, OTC, DMF   Bonuses with new procured accounts

Newport News, Virginia, Dilon Technologies® is headquartered in Newport News, Virginia and is searching for a Director of Regulatory Affairs/Quality Assurance, Clinical; this is a key leadership role within the Company.  We strive to improve the quality of life by providing a wide range of innovative medical solutions that benefit patients around the world. Dilon has a strong medical device portfolio; the Navigator System, a trusted brand and world-renowned surgical gamma probe for radio-guided lymphatic mapping and tumor localization, the MarginProbe, a ground breaking technology for accurate margin assessment in breast cancer surgery, and the CoPilot, an innovative, portable, and easy to use video laryngoscope.   IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME   Bachelor’s degree with 7 years of regulatory experience or Master’s degree with 5 years of regulatory experience  Experience in healthcare industry (i.e. medical device, pharma/drugs, biologics, biotech)  Experience in regulatory submissions (i.e. writing/developing/preparing/creating submission for Premarket Approval (PMA) for Class III medical devices, Investigational Device Exemption (IDE), EU technical files for Class IIa/IIb and design dossiers for Class III, clinical trials) Experience as a Management Representative leading a QMS  Nice to Have: Master’s Degree or Doctorate in Regulatory Affairs, Engineering, Quality or related technical field Expertise in IDEs, PMAs, 510(k)s, 180 Days, Design Dossiers, Technical Files,30 day Notices, and Real Time Reviews Experience with regulatory support of clinical trials Technically savvy; must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues Experience in assembling facts from various areas, analyzing data, and providing informed recommendations  Product experience with Radio Frequency (RF), Electromagnetic Compatibility (EMC), Software and Implantable devices and thorough knowledge of regulatory requirements Good working knowledge of FDA and international regulatory agency requirements, ISO/GHTF standards Regulatory Affairs Certification (RAC) Able to assess changes to design, process, labeling, packaging, sterilization and software to products in the market and under development for Regulatory reporting Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations. Ability to compile data and summarize results Organized, efficient, process-oriented; high attention to detail Effective interpersonal/communication skills Works well under pressure in a dynamic timeline-driven environment Ability to effectively manage multiple projects and priorities Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills  General Responsibilities: Preparation and maintenance of regulatory submissions and registrations of devices in the US (FDA) and Canada (Health Canada) Preparation and submittal of periodic reports for Class III devices in the US Preparation and maintenance annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses Review of customer complaints to determine regulatory reportability requirements; in collaboration with the Senior Quality Technician, preparation/submittal of regulatory reportable events Actively participate in the evaluation of changes to the QMS documents and device design/process for impact on pending or existing registrations Review complex reports, validations, etc. for scientific merit and regulatory appropriateness Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation; advise project teams on premarket regulatory requirements, labeling requirements and/or clinical study compliance issues Monitor and advise the Senior Quality Technician of upcoming or new guidance, regulations, agency/industry initiatives, etc. to ensure regulatory strategies are in alignment with company objectives Interpretation of regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures Participate in compliance activities that relate to the department and the company, when needed Work closely with various teams (i. e. Regulatory Affairs, R&D, Quality, Manufacturing and Marketing) located at HQ and ROW Apply business and RA ethical standards Perform due diligence; Assess and interpret regulatory requirements and their impact Work with cross-functional international teams Paid vacation; 401(k); Short and Long-term Disability; Eligibility for health, vision, and dental insurance.

Richmond, Virginia, Have 10 years of leadership experience in quality systems and operations with the FDA or in an FDA regulated environment? Have a passion for driving excellence and compliance in everything you do? If so, we want to speak with you!  We are currently seeking a  Manager, Regulatory Quality Compliance  to join our Regulatory Quality Audits & Requirements department in  Richmond, VA. This role will work with multiple business partners to prepare for FDA Tobacco Product Manufacturing Practice (TPMP)’s. You will collaborate with quality, manufacturing, and product development personnel to evaluate their quality systems and product processes. In this role, you will: • Generate TPMP gap assessments of existing processes and systems against Altria Quality Requirements (AQR) using multi-disciplined, multi-functional teams. Plan and conduct research on good manufacturing, good laboratory, good clinical practices, and product development requirements pertinent to FDA regulated industries to support the development of Altria Quality Requirements (AQR), Quality Management System (QMS) and general quality practices • Lead enterprise FDA Inspection Readiness Plans to support TPMP readiness activities. Develop proficiency in industry proposed TPMPs. Generate and lead project plans to address remediation plans. Generate metrics to track project progress • Develop, lead, and write position papers which define the rationale for TPMP response and interpretation • Conduct trend analysis and formulate management communications for emerging quality risks related to TPMPs • Craft and improve quality requirements and standards through independent research and interpretation of other FDA regulated industries and standards • Provide mentorship and recommendations to management on tobacco Manufacturing Practices (TPMP) implementation and issues resolution • Lead Quality Compliance activities with respect to TPMP readiness • Participate and/or lead QMS audits • Provide TPMP Quality Compliance support for Vendor and Supplier Management, including, but not limited to, Contract Manufacturing Organizations, Contract Labs, Quality Agreements, QMS infrastructure, and risk management • Advise on internal and external situations which may pose quality/compliance risks that may adversely affect business operations • Conduct analyses, consulting and assessments of various operations and processes by applying their knowledge and judgment in areas where they may have little to no previous work experience • Lead or participate in corrective actions and programs designated to improve the quality and compliance posture of the organization • Maintain confidentiality of information acquired during audits We want you to have: • Bachelor's degree in a Physical Science, Engineering or related field • Minimum of 10 years of leadership experience in FDA and or FDA regulated quality systems and operations (pharmaceuticals, medical devices, and dietary supplements). Experience in product development preferred. • Working knowledge of Data Integrity and product development related requirements. • Strong analytical and organizational skills • Strong written, verbal and presentation skills along with proven ability to collaborate with others • Ability to considerately, independently and persuasively provide critical and sensitive feedback to the most senior levels of management • Proficiency in conflict negotiation and resolution is preferred • Perform assignments in an independent and autonomous manner with minimal direct supervision • Able to utilize various computer software to include: Word, Excel, PowerPoint, and Outlook • Comfortable working during non-core hours as required to assess multiple shifts and operations spanning lengthy periods At Altria Client Services, we recognize that our people are the reason we achieve our business goals. We believe in developing the leadership potential of our employees by providing them with opportunities for training, development, and advancement.