Senior Regulatory Affairs Specialist
2 weeks ago
Role- Senior Regulatory Affairs Specialist
Location - Hampshire - Home working
Some travel to site every few months for collaborative projects
Supports Regulatory Affairs Project core team members on development teams, providing regulatory guidance, and project regulatory assessments. Liaises with internal functions such as Manufacturing, R&D, Operations and Marketing to provide any necessary information and documents (outside the Master Technical Files), requested by the regions to assist in global product registration activities. Responsible for supporting the development and administration of global regulatory policy positions across product lines by preparing EMEA regulatory submissions for the full range of product approvals. This responsibility includes working independently with Marketing, Product Development, Consultants and Dealers to consolidate information and documentation required for regulatory filings in numerous countries within EMEA. Providing support for plans to achieve identified corporate regulatory policy objectives. Also develops related strategies and tactics to achieve stated business unit objectives subject to regulatory authority oversight which affects business. Responsible for keeping abreast of and providing regular reporting to key business leaders on key regulatory developments that impact customers, or business directly. To share some of the responsibilities of the Person Responsible for Regulatory Compliance, with shared specific responsibility for the sub clause(s) of Article 15 (3) of the EU Medical Devices Regulation (MDR) 2017/745 described below.
The Senior Regulatory Affairs Specialist will provide Regulatory support and direction to products from concept to launch.
RA Specialist follows the regulatory strategy for assigned corporate projects. Assists in creating, developing, and implementing global regulatory affairs procedures for marketed products and to ensure company’s regulatory compliance status.
The Senior Regulatory Affairs Specialist fulfils some of the responsibilities of the Person Responsible for Regulatory Compliance, per Article 15 (3) of the MDR, in a shared capacity
Prepares, compiles, and submits regulatory documents for the registration of current and new products in assigned markets.
Maintains submission documents, and agile databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
Communicates to management any identified delays that may impact business expectations.
Monitors approved registrations in respect to expiry and ensures management is aware of action required to renew in a timely manner to ensure no disruption in product distribution.
Interacts with Regulatory Affairs personnel at regulatory agencies, consultants, contract manufacturers, and distributors to ensure requirements are understood and submissions are complete and accurate to avoid any potential delays in approval.
Monitoring Registration Requirements within Region
Works with in-country representatives, contractors or perform independent research to determine regulatory requirements for product registrations in responsible regions
Communicates applicable regulatory requirements to Regulatory Affairs management and business partners.
Analyses impact and communicates to management changes in regulations or requirements that have been identified.
Represents the perspective of regulatory affairs to the company.
Interprets general business objectives and effectively present information to manager and regions.
Supports“Own Brand” and “Private label “ customers and liaises with EU Competent Authorities and other Ministries of health as necessary
Provides input to Regulatory Affairs Impact Documents (RAIDS) from aUK EU, ACE & MENA perspective.
Responsible for exhibiting professional behaviour with internal and external business associates that reflects positively on The individual conveys a trustworthy, credible, and reliable image at all times.
Act as a resource to the regions on quality issues and propose changes to minimise risks and enhance quality, reliability, safety and productivity.
Act as spokesperson, when appropriate, regarding practices, public policy, business interests; Support RA compliance activities as necessary in assigned regions
This individual has autonomy to perform the duties of Person Responsible for Regulatory Compliance (PRRC) under the EU MDR. Travel Requirements :
Understanding of ISO 13485 requirements and EU medical device regulations.
Computer literate, with intermediate skill in the use of Word, Excel and Outlook, and some knowledge of relational database systems, e.g. Agile Project Management system.
Ability to work effectively either alone or as part of a team. Flexible and able to self-manage multiple priorities.
Full, current driving license
Office/Hybrid/Remote environment.
Prolonged use of a computer.
3-6 years of medical device regulatory experience. Technical writing experience. Has experience evaluating manufacturing changes for impact on global regulatory affairs submissions. Medical device industry experience including strong working knowledge and experience with MDD and MDR. Ability to operate in a business driven model providing quick, salient analysis and concrete action plans emphasis on understanding and anticipating business needs and interests and devising proactive approaches/responses. Extensive network-building and contact experience. Capability to interact effectively and credibly at senior levels. Bachelor’s degree in a scientific or technical discipline and working knowledge of medical device regulations.
regulatoryaffairs#regaffairs#regulatoryaffairs#MDR#MDD#EMEA#Medicaldevices
#
-
Senior Regulatory Affairs Specialist
2 days ago
England, United Kingdom Mosaic Regulatory Solutions Full timeRole - Principal Regulatory Affairs Specialist Location - Hampshire or Remote ( must be based in UK or Europe ) Role Status- Perm Supports Regulatory Affairs Project core team members on development teams, providing regulatory guidance, and project regulatory assessments. Responsible for supporting the development and administration of global regulatory...
-
Senior Regulatory Affairs Specialist
2 weeks ago
England, United Kingdom Mosaic Regulatory Solutions Full timeRole- Senior Regulatory Affairs Specialist Location - Hampshire - Home working Some travel to site every few months for collaborative projects Scope: Supports Regulatory Affairs Project core team members on development teams, providing regulatory guidance, and project regulatory assessments. Liaises with internal functions such as Manufacturing, R&D,...
-
Regulatory Affairs Specialist
4 days ago
England, United Kingdom Science Solutions Recruitment Full timeSenior Regulatory Specialist - Biocides - Hybrid/Remote Are you a Senior Regulatory Specialist / Regulatory Affairs Manager who would you like to work with a fast-growing business with lots of technical development planned for the next 3 years?? The role of Senior Regulatory Specialist offers you the chance to work with a globally recognised business with...
-
Regulatory Affairs Specialist
2 weeks ago
England, United Kingdom Hyper Recruitment Solutions Full timeWe are currently looking for a Regulatory Affairs Specialist to join a leading Distribution company based in the Kent area. As the Regulatory Affairs Specialist you will be responsible for maintaining the integrity and compliance of medicinal product imports, ensuring the highest standards are met in line with industry regulations. This will be a hybrid...
-
Regulatory Affairs Specialist
3 days ago
England, United Kingdom Science Solutions Recruitment Full timeSenior Regulatory Specialist - Biocides - Hybrid/Remote Are you a Senior Regulatory Specialist / Regulatory Affairs Manager who would you like to work with a fast-growing business with lots of technical development planned for the next 3 years?? The role of Senior Regulatory Specialist offers you the chance to work with a globally recognised business with a...
-
Regulatory Affairs Specialist
2 days ago
England, United Kingdom Science Solutions Recruitment Full timeSenior Regulatory Specialist - Biocides - Hybrid/Remote Are you a Senior Regulatory Specialist / Regulatory Affairs Manager who would you like to work with a fast-growing business with lots of technical development planned for the next 3 years?? The role of Senior Regulatory Specialist offers you the chance to work with a globally recognised business with a...
-
Regulatory Affairs Specialist
2 weeks ago
England, United Kingdom Hyper Recruitment Solutions Ltd Full timeWe are currently looking for a Regulatory Affairs Specialist to join a leading Distribution company based in the Kent area. As the Regulatory Affairs Specialist you will be responsible for maintaining the integrity and compliance of medicinal product imports, ensuring the highest standards are met in line with industry regulations. This will be a hybrid...
-
Regulatory Affairs Specialist
7 days ago
England, United Kingdom Hyper Recruitment Solutions LTD Full timeWe are currently looking for a Regulatory Affairs Specialist to join a leading Distribution company based in the Kent area. As the Regulatory Affairs Specialist you will be responsible for maintaining the integrity and compliance of medicinal product imports, ensuring the highest standards are met in line with industry regulations. This will be a hybrid...
-
Regulatory Affairs Specialist
1 week ago
England, United Kingdom Hyper Recruitment Solutions LTD Full timeWe are currently looking for a Regulatory Affairs Specialist to join a leading Distribution company based in the Kent area. As the Regulatory Affairs Specialist you will be responsible for maintaining the integrity and compliance of medicinal product imports, ensuring the highest standards are met in line with industry regulations. This will be a hybrid...
-
Dynamics Specialist
2 weeks ago
England, United Kingdom Mosaic Regulatory Solutions Full timeRIMS Senior Specialist - Amazing company - great career path Global company expanding its regulatory information management team in Hampshire. Seeking a Senior RIMS Specialist with at least 5 years of experience. Enjoy a flexible working environment, flat structure, and generous remuneration package. Apply for RIMS Senior Specialist - Amazing company -...
-
Regulatory Specialist and Senior Specialist
2 weeks ago
England, United Kingdom Hyper Recruitment Solutions Full timeWe are currently looking for a Regulatory Affairs Specialist to join a leading Distribution company based in the Kent area. As the Regulatory Affairs Specialist you will be responsible for maintaining the integrity and compliance of medicinal product imports, ensuring the highest standards are met in line with industry regulations. This will be a hybrid...
-
Regulatory Affair Specialist
5 hours ago
Wembley, England, United Kingdom Medicareplus International Ltd Full timeJob SummaryThe experience expected from applicants, as well as additional skills and qualifications needed for this job are listed below.RA Specialist is responsible for ensuring continued compliance of the Quality Management System of the company with the relevant Medical Device Regulations, International Standards, and Customer Requirements and that this...
-
Senior Director, Regulatory Affairs
10 hours ago
England, United Kingdom tranScrip Limited Full timeProvide regulatory affairs expertise to clients seeking regulatory strategic input to their development programmes. Applies senior regulatory affairs experience in other areas for the conduct of client projects. Supports BD and Marketing efforts to support company growth including client pitches, input into proposals, social media activity and speaking...
-
Senior Director, Regulatory Affairs
11 hours ago
England, United Kingdom tranScrip Limited Full timeProvide regulatory affairs expertise to clients seeking regulatory strategic input to their development programmes. Applies senior regulatory affairs experience in other areas for the conduct of client projects. Supports BD and Marketing efforts to support company growth including client pitches, input into proposals, social media activity and speaking...
-
Regulatory Affairs Specialist
4 days ago
England, United Kingdom Campden BRI Full timeRegulatory Affairs Advisor (Arabic Speaking)At Campden BRI, we have a dedicated Regulatory Affairs Team who offer a valuable and expert advisory service, as we're the leading authority, helping our clients stay compliant with food regulations in more than 80 countries! We are widely recognised for our expertise in the interpretation and commercial...
-
Regulatory Affairs Specialist
4 days ago
England, United Kingdom Campden BRI Full timeRegulatory Affairs Advisor (Arabic Speaking)At Campden BRI, we have a dedicated Regulatory Affairs Team who offer a valuable and expert advisory service, as we're the leading authority, helping our clients stay compliant with food regulations in more than 80 countries! We are widely recognised for our expertise in the interpretation and commercial...
-
Regulatory Affairs Specialist
4 days ago
England, United Kingdom Campden BRI Full timeRegulatory Affairs Advisor (Arabic Speaking)At Campden BRI, we have a dedicated Regulatory Affairs Team who offer a valuable and expert advisory service, as we're the leading authority, helping our clients stay compliant with food regulations in more than 80 countries! We are widely recognised for our expertise in the interpretation and commercial...
-
Regulatory Affairs Specialist
4 days ago
England, United Kingdom Campden BRI Full timeRegulatory Affairs Advisor (Arabic Speaking) At Campden BRI, we have a dedicated Regulatory Affairs Team who offer a valuable and expert advisory service, as we're the leading authority, helping our clients stay compliant with food regulations in more than 80 countries! We are widely recognised for our expertise in the interpretation and commercial...
-
Regulatory Specialist and Senior Specialist
2 weeks ago
England, United Kingdom Hyper Recruitment Solutions Ltd Full timeWe are currently looking for a Regulatory Affairs Specialist to join a leading Distribution company based in the Kent area. As the Regulatory Affairs Specialist you will be responsible for maintaining the integrity and compliance of medicinal product imports, ensuring the highest standards are met in line with industry regulations. This will be a hybrid...
-
England, United Kingdom Mosaic Regulatory Solutions Full timeRole - Principal Regulatory Affairs Specialist Location - Hampshire or Remote ( must be based in UK or Europe ) Salary - Negotiable Role Status- Perm Scope: Supports Regulatory Affairs Project core team members on development teams, providing regulatory guidance, and project regulatory assessments. Liaises with internal functions such as Manufacturing,...
