| Job Number: | 2351442 |
| Business: | GE Healthcare |
| Business Segment: | Healthcare Quality |
| About Us: | GE (NYSE: GE) is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. GE is organized around a global exchange of knowledge, the "GE Store," through which each business shares and accesses the same technology, markets, structure and intellect. Each invention further fuels innovation and application across our industrial sectors. With people, services, technology and scale, GE delivers better outcomes for customers by speaking the language of industry.
GE is committed to taking on the world’s toughest challenges. In order to fulfill that promise we rely on a culture of leadership, diversity and inclusiveness. We aim to employ the world´s brightest minds to help us create a limitless source of ideas and opportunities. We believe in hiring talented people of varied backgrounds, experiences and styles... people like you. |
| Posted Position Title: | Regulatory Affairs Leader (m/f) |
| Career Level: | Experienced |
| Function: | Quality |
| Function Segment: | Regulatory Affairs |
| Location: | Austria |
| U.S. State, China or Canada Provinces: | |
| City: | Pasching |
| Postal Code: | 4061 |
| Relocation Assistance: | No |
| Role Summary/Purpose: | The Regulatory Affairs Leader with focus on animal & non-animal materials provides subject matter expertise (production, import and export of animal and non-animal materials including communications with related regulatory authorities) and works with a team of regulatory affairs professionals to ensure GEHC establishes best practice within the assigned area of responsibility (regional regulatory submissions & reporting, technical standards, collection and dissemination of intelligence, etc). |
| Essential Responsibilities: | - Key to this position will be the ability to work with local and national regulatory authorities to obtain health certificates for animal derived material imports and exports.
- The successful candidate will know how to work well with local and veterinary national regulatory authorities.
- Work closely with regulatory, engineering, marketing, legal, and other professionals across the company to develop & implement company-wide programs and processes for regulatory affairs compliance within areas of responsibility.
- Identify regulatory trends and their implications for GE Healthcare; Develop & implement effective regulatory strategies to meet business objectives
- Analyze & communicate proposed, new or changing requirements, & devise strategies for their implementation, ensuring business goals are met.
- Scan the external environment and work with external associations to proactively adapt regulatory strategies and influence change within areas of responsibility.
- Educate, train, & advise company professionals to ensure compliance with RA requirements.
- Audit business units for compliance and consistency, and track/address trends observed that could lead to non-compliance, or risk to patient/user safety.
- Collect, summarize & evaluate performance metrics to identify program weaknesses & drive improvements in procedures or oversight.
- Support continuous improvement activities with regard to areas of responsibility.
- Drive improvements to overall Quality Management System documentation to provide clear flow down of regulations in areas of responsibility.
- Support with projects.
Quality Specific Goals - Aware of and comply with the GEHC Cell Culture Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
- Complete all planned Quality & Compliance training within the defined deadlines
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility
- Effectively support implementation & management of current regulatory requirements within area of responsibility
- Ensure assigned regulatory submissions are accurate, complete and timely
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| Qualifications/Requirements: | - Bachelor’s Degree & several years of experience in the medical device or pharmaceutical industry or government / government relations; OR significant progressive regulatory affairs experience in medical device or pharmaceutical industry or government / government relations, including knowledge & experience applying global drug or device laws & regulations for product registration, adverse event reporting, & recalls
- Ability to prioritize, plan & evaluate deliverables to established strategic goals
- Demonstrated experience operating in a highly regulated environment; Proven application of analytical skills in a regulatory environment
- Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research.
- Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner
- Prior experience using spreadsheet and presentation software
- Proficient command of English and German language
- Must be willing to travel up to 15% of time
Dependent on the qualification and experience the monthly gross salary provided for this position is a minimum of € 3,
000.00 based on full-time employment.
Interested? We are looking forward to your application on our website: www.ge.com/careers! For further questions please contact Mrs. Darya Lehmann, Senior Recruiter, at Tel. +49 89 962 816
54. |
| Additional Eligibility Qualifications: | |
| Desired Characteristics: | KARR_AUT |