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.
What you'll be doing
- Creates the regulatory strategy for all stages of development to drive the earliest and broadest possible approval of the company’s regulatory applications in a cost effective and compliant manner.
- Directs and manages interactions with all Regulatory Agencies including the FDA and international agencies
- Collaborate 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 acquisition
- Holds oneself and others accountable to conduct business in a manner compliant with Bioventus’ Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role. Attract, develop and retain talent.
- Ensure focus and alignment with functional and company goals. Provide employees with continuous feedback and coaching using talent-and-performance management tools.
- Collaborates with Audit & Risk Management function to identify business risks, and develop and implement preventive strategies for functional area.
- Other duties as assigned
What you'll bring to the table
- B.S. or B.A degree in a technical discipline (Biology, Chemistry, or Engineering preferred); advanced degree preferred (M.S.)
- 10-15 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 products
- Strong 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
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.
Are 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 of diversity, and take 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.
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