Regulatory Affairs Manager

Regulatory Affairs Manager 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. Key Responsibilities Prepare, provide direction and oversee documentation packages for submission to global regulatory authorities to register new and/or maintain global approvals/clearances for assigned 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. Prepare, collect, review and assemble technical documentation required for writing regulatory and clinically‑related submissions such as US 510K, PMAs, IDEs, NDAs, INDs or international dossiers for new and modified products. Liaise with project teams to develop regulatory strategies, testing requirements and other documentation to ensure regulatory data requirements are met. Work with stakeholders to serve as a point person for regulatory agency interactions, including preparation of briefing packages, presentations, and strategy for meetings, and response to agency letters pertaining to assigned products. Monitor proposed and current global regulations and standards; assess impact of changes on assigned biologics product lines. Maintain awareness of global regulatory legislation and assess its impact on development and manufacturing initiatives. Evaluate design, manufacturing and labeling changes to ensure compliance with FDA, international and other applicable governmental regulations. Identify and facilitate the remedy of inefficiencies in Quality systems and processes. Contribute to the Regulatory and/or Quality perspective on due diligence activities to identify issues related to the targeted product’s development and/or its manufacture. Hold 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. All other duties or projects as assigned. Education and Experience Bachelor’s degree required (study area in Engineering or life sciences preferred, but other degrees may be considered) Knowledge and experience working with biologics Extensive knowledge of FDA and applicable international regulations required. Working knowledge of US Quality Systems Regulations (QSRs) and/or Good Manufacturing Practices (GMPs), along with ISO 13485. Minimum of 5–7 years of Regulatory and Quality regulations experience and submission experience required. Class II medical device experience required; Class III medical device and/or PMA/BLA/NDA submissions experience desired. Excellent written, verbal communication and presentation skills required, including the ability to communicate clearly, concisely and effectively verbally and in writing. Solid interpersonal skills including the ability to remain calm, professional, diplomatic and positive. Being detail‑oriented while having the ability to handle multiple projects/tasks. Experience interacting with US FDA is required. Equal Opportunity Employer 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, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply. #J-18808-Ljbffr