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Vice President Regulatory Affairs

Company: Bioventus
Location: Durham
Posted on: September 24, 2022

Job Description:

Are you ready to work for a more active world?At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.Who is Bioventus?We are the market leader in developing clinically proven and cost-effective solutions for pain treatment & joint preservation, restorative therapies and bone graft substitutes with products recognized for their safety, innovation, and effectiveness.$500+ million in annual revenue1100+ employees worldwideHelping 700,000+ people every yearThe Bioventus team always puts patients at the forefront, and their needs are the priority in the choices we make and actions we take.Vice President Regulatory AffairsDurham NC or Farmingdale NY Full Time Hybrid office working. The Vice President of Regulatory is responsible for developing and executing global regulatory strategies designed to obtain regulatory approvals to support the business. The position will lead and direct all regulatory affairs activities, including international (OUS) product registrations and product regulatory compliance, in collaboration with Quality Assurance. This position will collaborate with R&D/Engineering, Marketing, Quality Assurance, Operations, Clinical/Medical Affairs, and other functional areas to provide regulatory expertise and strategies that successfully lead products through the FDA clearance/ approval process, as well as international regulatory agencies. The position will ensure that company policies, procedures and practices are in compliance with appropriate regulatory requirements. What youll be doingCreates the regulatory strategy for all stages of development to drive the earliest and broadest possible approval of the companys regulatory applications in a cost effective and compliant manner. Directs and manages interactions with all Regulatory Agencies including the FDA and international agenciesCollaborate with cross-functional teams to ensure that various regulatory pathways are reviewed and challenged early in the development process. Regularly present regulatory strategies, associated risks, and potential solutions to the relevant business units. This includes developing and presenting an assessment of the regulatory risks associated with the preferred regulatory strategies, along with the mitigation plans, to the project team and management in order to keep commercialization progress on track.Direct and contribute to the preparation of domestic U.S. [510(k)s, PMAs, etc.] and International regulatory filings for Business Unit products in accordance with policies and procedures established by the company and regulatory agencies. Prepares and submits all required annual, quarterly, and adverse event reports required by the FDA and other regulatory bodies in order to maintain regulatory compliance for approved products.Develop and maintain outstanding relationships with all regulatory and compliance agencies. Provide appropriate interface with global regulatory agencies in a variety of pre- and post-market forums. Provide guidance, interpretation, and opinions on complex regulatory matters (particularly related to submission pathways), outlining the different outcomes.Review and ensure product labeling and promotional materials are in compliance with FDA, Corporate, and international regulations, and requirements. Provide technical leadership, training, and vision by interpreting regulatory affairs initiatives and mandates, uncovering emerging trends and providing the processes necessary to meet challenging regulatory needs. Manage operational expenses in functional area of responsibility and participate in the preparation of overall expense budget and headcount forecast for Regulatory Affairs. Develop organizational structure, recruitment and talent development and maintain a high level of department engagement and performance.Review and approve promotional material to assure compliance with claims Partners with Senior Leaders to review and assess new technologies under consideration for internal development and acquisitionWhat youll bring to the tableB.S. or B.A degree in a technical discipline (Biology, Chemistry, or Engineering preferred); advanced degree preferred (M.S.) Strong business acumen10-15 years of experience in the Life Sciences business (medical device preferred) with a proven track record of product approvals in the U.S. and internationally. Experience in design and implementation of regulatory strategy for medical devices and/or combination productsStrong knowledge of the global regulatory environment and understanding of risk management; must have experience working with FDA as well as EU notified bodies (e.g. BSI, MEDCERT, Dekra, etc.) Understanding of EU Medical Device Regulations (MDR) requirements Experience working on FDA warning letters, Consent decrees, etc. and proven success in navigating FDA and other regulatory compliance challenges Must have a minimum of three (3) years as a Sr. Director or Vice President in a medical device company Strong technical knowledge and ability to interpret regulations and standardsAbility to work closely with Engineering / R&D to provide guidance on test needs to support regulatory submission (e.g. electrical standards, software verification and validation, biocompatibility, risk management, etc.) Must have experience preparing and finalizing regulatory submissions Ability to anticipate the business needs and align RA strategies with business Ability to work in a team environment, as well as a matrix reporting structure, including adaptability to changing priorities and a fast-paced work environment, as well as dealing with ambiguity, organizational agility, and strategic thinking Ability to attract, coach/mentor and develop RA talent as well as create and sustain a performance driven culture Must have strong verbal and written communication skillsWhat youll receive The satisfaction of driving real change in the industry and peoples livesA diverse global community of people who are driven by a shared purpose to help patientsA business that acts with integrity in all interactions with co-workers, leaders and customersWe value others and build success by appreciating differences in thought, opinion, background, skills and perspectivesAn environment of continuous learning and development Employee Stock Purchase PlanFlat organizational structures which elevate employees level of responsibilityMeaningful opportunities for professional development and mentoringCompetitive compensation package, including salary, equity, and bonusExciting benefits package, including 18 days vacation; medical, dental and vision benefits; Student Debt Program; life insurance; and a 401(k) planAre you the top talent we are looking for?Apply now! Hit the Apply button to send us your resume and cover letter.Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms ofdiversity, andtake pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, ability, gender, gender expression, gender identity, nationality, race, religion or sexual orientation.All individuals, regardless of personal characteristics, are encouraged to apply.Bioventus requires proof that new hires be fully vaccinated against COVID-19, unless you are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents you from being vaccinated where allowable under the law. Documentation is required to be uploaded within the first week of employment.

Keywords: Bioventus, Durham , Vice President Regulatory Affairs, Executive , Durham, North Carolina

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