Senior Regulatory Affairs Specialist

Role- 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, 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.

Job Summary:

The Senior Regulatory Affairs Specialist will provide Regulatory support and direction to products from concept to launch.

The Sr. 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

Essential Functions & Accountabilities:

• 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.
• Monitors pending submissions to ensure timely approvals. 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
• Maintains up-to-date knowledge of regional and national regulations, guidelines, and advisory documents required for marketing products in a specified region.
• 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.

Compilation of Technical Documentation

• Authors STED and GSPR documents and compiles Notified Body submissions in line with Technical documentation procedures for MDD and or MDR.
• Supports RA Management with Notified Body requests for information.

Support to Processes

• Represents the perspective of regulatory affairs to the company.
• Interprets general business objectives and effectively present information to manager and regions.
• Reviews and approves product labelling.Initiates IFUs and other required product labelling in line with relevant UK, EU, ACE & MENA requirements.
• 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.
• Undertakes other administrative tasks to support CE marking and regional registrations.
• 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; arrange for technical explanations from internal or external experts.
• Support RA compliance activities as necessary in assigned regions

PRRC

• Ensures that, per Article 15 (3) of the MDR:
• the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
• the post-market surveillance obligations are complied with in accordance with Article 10(10) of the MDR;
• the reporting obligations referred to in Articles 87 to 91 of the MDR are fulfilled;

in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of the MDR is issued.

This individual has autonomy to perform the duties of Person Responsible for Regulatory Compliance (PRRC) under the EU MDR. This individual shall suffer no disadvantage within the organization in relation to proper fulfilment of his or her duties in lieu of article 15 of the EU MDR.

Travel Requirements :

Qualifications

Knowledge, Skills and Abilities:

• Understanding of ISO 13485 requirements and EU medical device regulations.
• Ability to read and understand technical material.
• Excellent attention to detail
• Excellent organization skills
• Excellent written and verbal communication skills.
• Excellent organizational skills.
• 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. Managing time effectively and completing tasks on time with general supervision.
• Experienced at reviewing and approving product labelling.
• Flexible and able to self-manage multiple priorities.
• Able to work effectively in multinational/multicultural environments.
• Flexibility to work across the UK sites
• Full, current driving license

Work Environment:

• Office/Hybrid/Remote environment.
• Prolonged use of a computer.
• Light lifting and bending.

Experience:

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. Must have the ability to build relationships and influence decision makers. Comprehension of industry developments and changes in the political environment. Extensive network-building and contact experience. Capability to interact effectively and credibly at senior levels. Experience in electronic document management systems Strong IT skills, problem solving ability, analytical and communication skills.

Education:

• Bachelor’s degree in a scientific or technical discipline and working knowledge of medical device regulations.

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