Senior Regulatory Affairs Associate-00000S7O
Description
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
Position Title: Senior Regulatory Affairs Associate
Location: Leeds, UK
Closing Date: 17th August 2014
Position Summary:
The Senior Regulatory Affairs Associate will provide full support to all regulatory activities, CE marking and regulatory submissions throughout the world. Responsibilities include the following:
- establish and maintain processes for submissions, interim notifications and periodic resubmissions;
- maintain information on world-wide regulatory requirements and the status of product registrations;
- develop and propose regulatory pre-market strategies in cooperation with other departments, and other DePuy Synthes locations as required;
- work cooperatively with Product Development groups to achieve compliance with regulatory requirements;
review document, process and product Change Orders for compliance with regulatory requirements;
- review/approve labeling: device labels, brochures, technique guides, bulletins, updates, etc.
- reviewe promotional materials for compliance with regulatory clearance/approvals.
- participate in cross-functional projects teams and our compliance program-related activities as required;
- co-ordinate registrations with external regulatory bodies, distributors and subsidiaries.
Qualifications
Education and Experience:
- Ideally qualified to a minimum of first degree level in a relevant scientific discipline, you will have a good depth of regulatory experience covering medical devices and/or pharmaceuticals across a range of markets
- A commanding knowledge of worldwide regulatory procedures, including medical devices, is also important
- Achievement focused, you’ll have great project management skills, a proven track record of delivery within timescales
- a collaborative style coupled with a pragmatic, “can do” approach
- Good IT skills, including data collection and general analysis tools.
What type of mark will you make? Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your experience; express your passion and touch the world.
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
We respectfully request Government Officials to identify themselves as such on application; for the purposes of the Foreign Corrupt Practices Act.
Primary Location:Europe/Middle East/Africa-United Kingdom-England-Leeds
Organization: Depuy Int'l Ltd. (8722)
Job Function: Regulatory Affairs
Description
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
Position Title: Senior Regulatory Affairs Associate
Location: Leeds, UK
Closing Date: 17th August 2014
Position Summary:
The Senior Regulatory Affairs Associate will provide full support to all regulatory activities, CE marking and regulatory submissions throughout the world. Responsibilities include the following:
- establish and maintain processes for submissions, interim notifications and periodic resubmissions;
- maintain information on world-wide regulatory requirements and the status of product registrations;
- develop and propose regulatory pre-market strategies in cooperation with other departments, and other DePuy Synthes locations as required;
- work cooperatively with Product Development groups to achieve compliance with regulatory requirements;
review document, process and product Change Orders for compliance with regulatory requirements;
- review/approve labeling: device labels, brochures, technique guides, bulletins, updates, etc.
- reviewe promotional materials for compliance with regulatory clearance/approvals.
- participate in cross-functional projects teams and our compliance program-related activities as required;
- co-ordinate registrations with external regulatory bodies, distributors and subsidiaries.
Qualifications
Education and Experience:
- Ideally qualified to a minimum of first degree level in a relevant scientific discipline, you will have a good depth of regulatory experience covering medical devices and/or pharmaceuticals across a range of markets
- A commanding knowledge of worldwide regulatory procedures, including medical devices, is also important
- Achievement focused, you’ll have great project management skills, a proven track record of delivery within timescales
- a collaborative style coupled with a pragmatic, “can do” approach
- Good IT skills, including data collection and general analysis tools.
What type of mark will you make? Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your experience; express your passion and touch the world.
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
We respectfully request Government Officials to identify themselves as such on application; for the purposes of the Foreign Corrupt Practices Act.
Primary Location:Europe/Middle East/Africa-United Kingdom-England-Leeds
Organization: Depuy Int'l Ltd. (8722)
Job Function: Regulatory Affairs