Johnson & Johnson Careers
Senior Regulatory Affairs Associate
Requisition ID: 1700204575W
We have an amazing opportunity for a Senior Regulatory Affairs Associate. Reporting in to the Regulatory Affairs Manager, leading worldwide product registrations and CE marking activates to ensure timely and systematic approvals are made in accordance with regulatory and business requirements.
WHAT YOU’RE GREAT AT:
- You will be results driven and be able to apply your excellent planning, interpersonal and time management skills to ensure new products obtain the necessary regulatory registrations in line with business objectives.
- Having an innate ability to develop and implement effective strategies and can communicate these effectively to your internal department, worldwide company colleagues and regulatory authorities.
- Having a strong sense of personal responsibility, be an individual leader and be a strong team member. Partner management will be key to your success.
- welcoming and seeking out challenging situations as opportunities to grow, something recognizable by the appreciative and rewarding working environment that is DePuy Synthes.
- Effectively managing regulatory activities to ensure the department supports business objectives by providing full support to CE marking, registration activities and regulatory submissions.
- Collaborating with New Product Development in the development of new products and technologies delivering effective regulatory strategy for product commercialization.
- Establish and maintain processes for the status and maintenance of registrations, interim notifications and periodic re-submissions.
- Assessing, developing and implementation of regulatory strategies and plans for changes to manufacturing sites, processes, global product transfers and legal manufacturer transfers.
- Establishing and maintaining good relationships with Regulatory Authorities, Regulatory colleagues at DePuy Synthes companies and distributors; and to provide support and advice to company colleagues.
- In conjunction with other departments, supporting the company’s post marketing surveillance responsibilities and vigilance activities.
- Maintaining awareness of developments of regulatory environments (worldwide), and addressing regulatory requirements as appropriate.
QUALIFICATIONS AND EXPERIENCE
Are you passionate about the next step in your career? We are looking for the following experience and background?
- A good first degree in a relevant discipline or significant regulatory expertise developed through experience and a positive track record.
- Drug-device and/or Pharmaceuticals experience gained in Regulatory Affairs or Quality functions.
- Significant regulatory & change management experience covering medical devices and/or pharmaceuticals
- Commanding knowledge of worldwide regulatory procedures, especially for medical devices.
- Experience gained working in worldwide markets, with a proven record of achievements
- Able to demonstrate projects undertaken have been satisfactorily completed within agreed timescales.
- Possess computer competency in Microsoft office software, data collection and general analysis tools.
Within DePuy Synthes we are always looking for future leaders so this position will give you phenomenal visibility to showcase your talents and develop your career. We will support you to develop both technically and personally. With our support, you will craft the site with autonomy, you will grow this role and your success will be visible across the organization. This really is a chance to join a growing team and take it to full maturity.
If you are waiting for your career to excel to the next level then this is one in a lifetime opportunity to join the world’s leading health care provider.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Depuy Int'l Ltd. (8722)