A Regulatory Affairs Manager plans, directs, or coordinates production activities of an organization to ensure compliance with regulations and standard operating procedures.
Onsite, Hybrid Schedule (3 Days Onsite / 2 Days Remote), 1st
Shift Hours Campus:
Indianapolis Indiana Campus About BCforward BCforward is a leading global IT consulting and workforce solutions firm providing services and support to Fortune 500 and government clients. Founded in 1998, BCforward has grown with our customers needs into a full-service business solutions provider. With delivery centers and offices across North America and India, we take pride in building long-term relationships and delivering excellence through innovation, collaboration, and integrity. Job Description We are seeking a US Regulatory Affairs Manager I to join our team. The ideal candidate will have strong experience in global regulatory submissions, IVDs/medical devices/biopharma regulations, and regulatory change control and a proven ability to secure and maintain product approvals across multiple regions while driving cross-functional alignment and timely registration outcomes .
Responsibilities:
Coordinate and compile regulatory submission dossiers to meet planned product registration timelines. Develop and manage parts of comprehensive global regulatory submission and registration plans for complex products or programs. Maintain approvals and licenses through effective regulatory change control across the product life cycle. Partner with internal stakeholders and external bodies (authorities, notified bodies, partners) to resolve issues and advance regulatory strategies. Contribute to audit preparation and participate in audit discussions as needed. Lead adaptation to evolving global regulatory requirements and interpret regulator expectations to guide projects across regions. Create innovative regulatory strategies to avoid obstacles and accelerate worldwide approvals. Influence and negotiate with stakeholders to reach outcomes that align business and regulatory objectives. Exercise sound judgment and timely decision making, escalating or delegating to the appropriate level. Drive problem solving and continuous improvement to ensure compliant, efficient daily operations. Model VACC leadership behaviors, foster inclusion, and mentor junior regulatory staff. Promote data stewardship and effective use of regulatory tools to support digitalization and strategic goals. Facilitate teamwork and clear communication, resolve conflicts constructively, and recognize contributions.
Required Skills & Qualifications:
3-5 years with PhD, 5-7 years with Master's, or 6-8 years with Bachelor's in IVDs, medical devices, pharma, or biopharmaceuticals with significant regulatory affairs experience or equivalent. Proven experience compiling and leading parts of global submissions and managing complex regulatory work. Knowledge of US, EU, and China regulations with the ability to interpret and implement quality and regulatory standards. Strong stakeholder management, negotiation, and cross-functional collaboration skills. Demonstrated decision-making skills and ability to act with limited information while maintaining compliance. Experience with Daily Management and Continuous Improvement best practices.
Preferred Skills:
Experience interfacing with health authorities or notified bodies and supporting audits. Background in data stewardship, regulatory information management tools, and digital ways of working. Why BCforward? At BCforward, we believe in advancing lives and careers. When you join our team, you gain access to: Competitive compensation and benefits Opportunities for growth with global clients A supportive, inclusive culture that values innovation and people Exposure to cutting-edge technologies and projects About Our Commitment BCforward is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, or veteran status. Interested? Apply Now! If this sounds like the right opportunity for you, please apply with your most recent resume.
