Senior Regulatory Consultant - Combination Products

A 12 month remote based contract opportunity.

A worldwide biotechnology company situated in Berkshire and operating in over 70 markets worldwide is looking for a Senior Regulatory Consultant - Combination Products. The company specialises in neurological conditions and puts a great emphasis on teamwork and delivering biological products.

Purpose of the Job:

• Expert in global combination products, medical devices, and digital health regulations, preferably US and EU.
• Responsible for developing and implementing innovative global regulatory strategies for product development and approval. Responsible for defining strategies for meeting and keeping post-approval compliance.
• Responsible for regulatory documents, submissions, and compliance issues.
• Represent the company with regulatory authorities, contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committees.
• Reports into Senior Director. Manages mid to high level professional employees. May manage low level supervisors or managers

• Responsible for defining and implementing regulatory strategies, including filing of all appropriate regulatory submissions for assigned programs, including responses to questions from the Health Authorities, Notified Bodies. Secure alignment across functions and with partners.
• Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks. Provide regulatory guidance to company personnel throughout the research and development process. Direct the organization and preparation of clear and effective submisions.
• Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development. Provide input to Senior Management teams as required. Maintain a global view as part of the whole regulatory team.
• Responsible for program leadership or consultative position that spans multiple business units
• Influences the development of goals and objectives for a large department or Business Unit
• Demonstrates intellectual leadership broadly within group and on multiple projects or programs. Collaborates and influences cross?functionally to ensure objectives are met.
• Manage 2 direct reports and 2-3 external consultants in carrying out responsibilities. Responsible for coordinating activities and career development of direct reports. Hands-on to provide operational/tactical support to the team, where needed.

• Minimum 6-8 years pharmaceutical/biotechnology/device industry experience, preferably minimum 5 years combination products and medical device regulatory experience.
• BS University degree required, Life/Health Sciences preferred.
• In-depth understanding of regulatory function with good knowledge of related quality, engineering, clinical, safety, post-market functions.
• Knowledge and understanding of applicable international regulations US FDA, EU MDR and standards particularly those relevant to combination products and medical devices.
• Experience within medical devices industry, preferably novel drug delivery combination products (drug delivery systems e.g., intrathecal port/catheter, transdermal patch, gene therapy, prefilled syringe, prefilled pen) and medical devices including SaMD (software as medical devices).
• Experience in global submissions including EU CE technical file, 510k, PMA, device CTD content within BLA & MAA, plus experience in post-market surveillance, design controls (21 CFR Part 820, Part 4, ISO 13485) including risk management, human factors/usability studies, clinical evaluation, control strategies, labelling.

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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