Regulatory Affairs Specialist overseeing regulatory submissions in SEA for global medical device company. Ensuring compliance and managing stakeholder communications for product regulations.
About the role
- Regulatory Affairs Manager developing regulatory strategies for product creation and market entry at BD. Collaborating with teams to identify regulatory changes and ensure compliance.
Responsibilities
- Working closely with the Director of Regulatory Affairs, the Regulatory Affairs Manager – RA Strategy Lead will provide proactive regulatory surveillance.
- They will develop regulatory strategies for product creation and market entry.
- They will serve as the regulatory advisor on innovation teams.
- This role is critical for proactively identifying regulatory changes and effectively communicating them to the business.
- Ensure swift understanding and compliance planning.
- Support the innovation council by providing upfront regulatory assessments to help guide planning through timely concept and product development.
- Engage in policy shaping to allow the business to navigate the regulatory landscape effectively.
- 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.
Requirements
- 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
- Discretionary LTI 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
- 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
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