Description :
The candidates will work with client & Our client's teams to deliver best in-class solutions for regulatory submissions. Assist in the creation of technical documentation (technical files and design dossiers) for Spine products that will meet the requirements of the new Medical Device Regulation (MDR) in the European Union.
The requirement is for 3 Regulatory Affairs Specialist.
Responsibilities :
- Identify reference documents for technical documentation including, but not limited to design and risk documents, verification / validation documents, standards conformance, and labeling.
- Identify and adhere to policies, procedures and work instructions which support technical documentation activities.
- Provide support for Clinical Evaluation Reports including references to required documentation.
- Align technical documentation according to OneMD technical documentation structure proposed by the MDR team.
- Prepare technical documentation for submission to and reviewed by Notified Bodies, as required.
- Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies.
- Maintain information on worldwide regulatory requirements and the status of product registrations.
- Be responsible for adherence to timelines and ensure milestones are achieved.
- Report issues to the Customer and Our Client management to ensure appropriate closure.
- Work with Our client teams at offshore and at other geographies.
Qualifications :
Experience Required :
- Strong knowledge of EU Medical Device regulations and guidance documents as well as relevant standards.
- Experience of Tech File and technical Documentation for submission to notified bodies
- Ability to work with cross-functional team members including (but not limited to) R&D, Quality, Labelling, Sterility, Medical and Clinical.
- Experience in working with PLM systems (i.e. Agile and Windchill)
- Proficient with MS Office applications such as MS Word, Excel.
- Excellent communication and inter-personal skills.
- Ability to manage multiple tasks and be detail-oriented.
- Knowledge of German is a plus
Generic Managerial Skills :
- Highly developed negotiation and influencing skills
- Highly developed and proven written and oral communication skills
- Organizational / planning skills
- Strong analytical skills
- Comfortable with using and facilitating a variety of problem solving methodologies
- Mentors and develops junior staff within the Our client delivery organization
- Willing to work with offshore teams in remote locations
Education :
Bachelor of Engineering (Mechanical, Biomedical preferred) or Bachelor of Science (Biology or Chemistry)
Regulatory Affairs Specialist
Are you a passionate IT trailblazer – a growth focused, problem solver who takes full ownership of your work, wants to collaborate & co-create with fellow IT experts, innovate, learn new skills, create new solutions & drive your career to the pinnacle of your potential? If so, you will love working....
Specialist - Regulatory Affairs - Labeling
The Labeling Specialist supports the development of labeling activities for all regulatory submissions. This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Effective collaboration with Regulatory Affairs, CMR, Supply Chain, a...
Senior Specialist, CMC Regulatory Affairs
CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compl...
Regulatory Affairs Specialist
The requirement is for 3 Regulatory Affairs Specialist. The candidates will work with client & Our client's teams to deliver best in-class solutions for regulatory submissions. Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to re...
Senior Regulatory Affairs Specialist
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society. Compile, prepare, and review regulatory submission to US and EU. Anticipate regulatory obstacles and emerging issues throughout the product submission. Provide regulatory input for responsible countries/region fo...
Specialist - Regulatory Affairs - Labeling
The Labeling Specialist supports the development of labeling activities for all regulatory submissions. This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Effective collaboration with Regulatory Affairs, CMR, Supply Chain, a...
Regulatory Affairs Specialist
Regulatory expert support IVDR teams, implements regulatory strategies for IVDR activities; provides regulatory leadership; collaborates with the regulatory staff from other business units, companies, government agencies as needed to develop harmonized policies, procedures and work instructions for ...
Regulatory Affairs Specialist
Determine appropriate regulatory requirements and strategies for new product development projects including both domestic and foreign activities and provide regulatory consultation to other internal and external entities. Must make a proactive contribution to the overall Regulatory affairs departmen...
Regulatory Affairs Biologicals labeling specialist
Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance. Support regulatory filing submissions with the USDA for both domestic and international product packaging. ...
USA-Regulatory Affairs Specialist Project Lead I (Scientific)
Regulatory Affairs Specialist Project Lead I (Scientific). This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Ea...