BD Nogales Norte · 2 weeks ago
Regulatory Affairs Manager - RA Strategy Lead (Hybrid)
Franklin Lakes, NJ
Full-time
Hybrid
Senior Level
$132K/yr - $218K/yr
5+ years expBD is one of the largest global medical technology companies in the world, seeking a Regulatory Affairs Manager – RA Strategy Lead. This role involves developing regulatory strategies for product creation and market entry while proactively monitoring regulatory changes and engaging with innovation teams.
Consumer Goods
Responsibilities
Proactively monitor global regulatory developments to identify potential impacts on product portfolio. Deliver timely and actionable insights to stakeholders, ensuring alignment with business strategy
Collaborate with cross-functional teams to develop plans addressing evolving regulations and standards that support product innovation and entry into markets
Serve as a regulatory advisor to innovation teams, providing mentorship on compliance and guidelines throughout the product lifecycle. Facilitate knowledge sharing to integrate regulatory considerations early in the development process
Assess potential regulatory risks associated with product development and market strategies. Propose and implement mitigation strategies to safeguard our innovation efforts
Responsible for effectively communicating trends in regulatory changes early to the organization. Ensure that all teams are informed and prepared to adapt to upcoming changes, fostering a proactive compliance culture
Champion a culture of regulatory excellence by providing training and support to internal teams. Foster awareness and understanding of regulatory obligations across the organization
Qualification
Required
Bachelor's degree required in Life Sciences, Engineering, or a related field
Minimum of 5 years of experience in regulatory affairs within the medical device industry
Comprehensive understanding of medical device regulations, standards, and the regulatory submission landscape (e.g. FDA, EU MDR, EU IVDR, ISO)
Proven experience in developing and implementing regulatory strategies
Exceptional analytical and strategic thinking abilities
Strong communication and interpersonal skills, with a proven ability to influence stakeholders
Effective project management skills and attention to detail
Proactive, adaptable, and results-driven, with a passion for regulatory excellence and innovation
Ability to work collaboratively in a cross functional team environment
Knowledge of quality management systems and risk management principles
Benefits
Annual Bonus
Potential DiscretionaryLTI Bonus
Medical coverage
Health Savings Accounts
Flexible Spending Accounts
Dental coverage
Vision coverage
Hospital Care Insurance
Critical Illness Insurance
Accidental Injury Insurance
Life and AD&D insurance
Short-term disability coverage
Long-term disability insurance
Long-term care with life insurance
Anxiety management program
Wellness incentives
Sleep improvement program
Diabetes management program
Virtual physical therapy
Emotional/mental health support programs
Weight management programs
Gastrointestinal health program
Substance use management program
Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
BD 401(k) Plan
BD Deferred Compensation and Restoration Plan
529 College Savings Plan
Financial counseling
Baxter Credit Union (BCU)
Daily Pay
College financial aid and application guidance
Paid time off (PTO), including all required State leaves
Educational assistance/tuition reimbursement
MetLife Legal Plan
Group auto and home insurance
Pet insurance
Commuter benefits
Discounts on products and services
Academic Achievement Scholarship
Service Recognition Awards
Employer matching donation
Workplace accommodations
Adoption assistance
Backup day care and eldercare
Support for neurodivergent adults, children, and caregivers
Caregiving assistance for elderly and special needs individuals
Employee Assistance Program (EAP)
Paid Parental Leave
Support for fertility, birthing, postpartum, and age-related hormonal changes
Bereavement leaves
Military leave
Personal leave
Family and Medical Leave (FML)
Jury and Witness Duty Leave
Company
BD Nogales Norte
Somos una empresa multinacional dedicada a la manufactura de dispositivos de uso médico a través de los cuales seguimos impulsando el mundo de la salud.
1001-5000 employees
H1B Sponsorship
BD Nogales Norte has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Late StageCompany data provided by crunchbase