Regulatory affairs Jobs in Durham, NC

Regulatory Affairs Manager

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.

The Regulatory Affairs Manager is responsible for developing and executing global regulatory strategies to plan, prepare, and obtain approvals and compliance with national and international regulatory requirements (e.g. U.S FDA, Health Canada, EU notified bodies, etc.), as well as work collaboratively with R&D/Engineering and Operations, Clinical/Medical Affairs, and other functional areas to provide regulatory expertise. The position will ensure that company policies, procedures and practices follow appropriate regulatory requirements.

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.
• Prepares, collects, reviews, and assembles 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.
• Liaises with project teams to develop regulatory strategies, testing requirements and other documentation to ensure regulatory data requirements are met.
• Works with stakeholders to serve as a point person for regulatory agency interactions, including preparation of briefing packages, including 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 to such on assigned biologics product lines.
• Maintains awareness of global regulatory legislation and assesses its impact of development and manufacturing initiatives.
• Evaluates design, manufacturing and labeling changes to ensure compliance with FDA, international, and other applicable governmental regulations.
• Identifies and facilitates in 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.
• 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.
• All other duties or projects as assigned.

Education and Experience (Knowledge, Skills & Abilities) Bachelor's degree required (study area in Engineering or life sciences preferred, but other degrees may be considered) Knowledge & 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 are 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

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.

Innovations for Active Healing that Enhance the Body's Ability to Heal Bioventus is a global leader of innovations for active healing. Through a combination of internal product development, product/business acquisition, and distribution agreements, we will bring to market products which address a growing need for clinically effective, cost efficient, minimally invasive medical treatments, that engage and enhance the body's natural healing processes.