Responsibilities :
1. Provides regulatory leadership strategic direction fARC regulatory programs, including global RA support fregistration planning, submissions, notified body quality system audits, program implementation across a cross-functional team with communication to leadership. Supports compliance of premarket submissions/registrations post market compliance, working closely with healthcare regulatory bodies globally.
2. Develops regulatory strategies to help optimize regulatory submission pathways, taking consideration regulatory requirements (including product testing, clinical data, etc), product claims country regulatory dependencies to ensure optimized sequencing fsubmissions.
3. Explains information clearly with the right level of detail fthe audience, works to understa situation, potential risks, develop possible solutions; brings team members to consensus around topics within the field.
4. Recognizes when additional support from senilevels within RA is needed to ensure sound decisions are made risks are minimized.
5. Utilizes technical expertise judgement to solve problems. Leverages technical skills analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.
6. Assesses changes in existing products determines the need fnew / revised licenses registrations.
7. Reviews approves advertising promotion material to ensure consistency with approved claims regulatory requirements.
8. Contributes to writing editing technical documents
9. Researches, analyzes, integratesganizes background information from diverse sources fregulatory submissions
10. Understands applies regulatory requirements their impacts fsubmissions pre- post-market compliance.
Qualifications :
1. This role requires advanced experience in the Quality & Regulatory Affairs. Knowledge level is comparable to a Bachelors degree from an accredited university college. 2. Minimum of 3 years experience working in a regulated field 3. Strong communication skills in English (both writtenal).
Characteristics :
1. Strong communication, project management,ganizational skills 2. Ability to work independently in fast-paced environment adapt to change. 3. Has ability to prioritize information fdata analysis recognize when additional information support is needed. 4. Team-oriented responsive to customer needs. 5. Attention to Detail Results-Oriented. 6. Ability to understtechnical documentation execute associated procedures
Inclusion Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national ethnicigin, sex, sexualientation, gender identity expression, age, disability, protected veteran status other characteristics protected by law.
We expect all employees to live breathe our behaviors: to act with humility build trust; lead with transparency; deliver with focus, drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost flexibility you need to turn your ideas world-changing realities. Our salary benefits are everything you’d expect from anganization with global strength scale, you’ll be surrounded by career opportunities in a culture that fosters care, collaboration support.
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