Senior Regulatory Affairs Specialist

Johnson & Johnson; Remote; GBP 45,000 - 60,000; Full time

Job summary

A global healthcare leader is seeking a Senior Regulatory Affairs Specialist to join their team in the United Kingdom. This full-time position requires robust experience in Regulatory Affairs with healthcare products. The candidate will ensure compliance with regulatory regulations, support technical documentation, and develop knowledge of key market regulations. Strong communication and analytical skills are essential to connect with internal and external stakeholders. Join a pioneer in innovative medical solutions and enhance patient care across various healthcare sectors.

Qualifications

• Minimum 3 to 5 years of Regulatory Affairs or related experience.
• Experience with healthcare products industry and regulations.
• Fluent in English, both written and spoken.

Responsibilities

• Ensure compliance with regulatory agency regulations.
• Support the creation of Technical Documentation for MDR CE marking.
• Develop knowledge of upcoming global key market regulations.

Skills

Regulatory Affairs Compliance

Analytical Reasoning

Communication

Problem Solving

Teamwork

Education

Bachelor’s degree in science, biomedical engineering, or equivalent

Job description

At Johnson & J N, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional

Locations

Diegem, Flemish Brabant, Belgium, Duelmen, Germany, Hamburg, Germany, Issy-les-Moulineaux, France, Lisbon, Portugal, Livingston, West Lothian, United Kingdom, Madrid, Spain, Warsaw, Masovian, Poland, Westport, Mayo, Ireland, Wokingham, Berkshire, United Kingdom

Job Description

We are searching for the best talent for a Senior Regulatory Affairs Specialist to join our Regulatory Affairs Global Strategy & Implementation team in Germany, UK, Spain, Belgium, Poland, Portugal or France.

This is a full-time, permanent position.

About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Key Responsibilities

• Ensure compliance with regulatory agency regulations and interpretations.
• Support the creation and implementation of regulatory strategies, including collaborating with cross functional teams (e.g., Business Unit Regulatory Affairs, Research & Development, Clinical, Quality, Regulatory Compliance and Marketing).
• Support the creation of Technical Documentation for MDR CE marking (Life Cycle Management and New Product Development projects).
• Support submissions to Notified Bodies and/or Competent Authorities (MDR, UKCA, initial applications, scope extensions, change notifications).
• Act as a strategic partner for Notified Body (NB).
• Develop knowledge of specific upcoming global key market regulations, communicate changes and support impact assessments to help Ethicon Business Units prepare for compliance in such markets.
• Perform the regulatory review of claims and marketing/promotional materials for copy approval purposes.
• Communicate business related issues or opportunities to next management level.
• Provide Regulatory Affairs support during internal and external audits.
• Ensure compliance with all Federal, State, Local and Company regulations, policies and procedures.
• Follow all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage staff, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.

Requirements

• A minimum of a bachelor’s degree in science, biomedical engineering, medical/scientific writing, law, public health administration or equivalent.
• A minimum of 3 to 5 years of Regulatory Affairs or related/equivalent experience.
• Experience with healthcare products (Consumer and/or Pharmaceutical and/or Medical Device) industry and regulations.
• Working knowledge of EU Medical Device regulatory matters including Medical Device Regulation (MDR).
• Analytical problem-solving skills.
• Fluent in English, both written and spoken.
• Excellent communication and interpersonal skills.
• Ability to present to internal and external audiences.
• Ability to work both independently and in a team environment.

Required Skills

Regulatory Affairs Compliance

Preferred Skills

• Analytical Reasoning
• Biomechanical Engineering
• Business Behavior
• Business Writing
• Communication
• Confidentiality
• Data Reporting
• Detail-Oriented
• Law
• Legal Support
• Medicines and Device Development and Regulation
• Problem Solving
• Product Licensing
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Development
• Regulatory Environment
• Risk Assessments
• Teamwork

EEO Statement

Johnson & J N is committed to providing an interview process that is inclusive of our applicants’ needs.