Regulatory Affairs Professional

We are seeking a Regulatory Affairs Specialist to join our team. This role will provide strategic leadership and direction for regulatory affairs across product development process, submissions and regulatory compliance.

• This position will be responsible for providing positive relationships with device reviewers through oral and written communications regarding pre-submissions strategy/regulatory pathway development testing requirements, clarification and follow-up of submissions under review.
• The successful candidate will assist with departmental policy and procedure implementation.
• The Regulatory Affairs Specialist will also assist with regulatory affairs training to cross functional groups.
• This role will generate and implement regulatory strategies for new and modified medical devices.
• The specialist will act as a core member on manufacturing and development teams, providing regulatory affairs feedback and guidance throughout the product development cycle.
• Responsibilities include preparation and submission of regulatory applications, as well as internal regulatory file documentation.
• The specialist will review and update eu regulatory documentation including technical documentation and post market surveillance deliverables such as sscps.
• The role requires preparation of fda regulatory files such as pre-market approval (pma's), supplements and amendments, 30-day notices, annual reports and 510ks.
• The Regulatory Affairs Specialist will review device labeling and advertising materials for compliance with global submissions and applicable regulations; analyzes and recommends appropriate changes.
• The specialist will interface with manufacturing, engineering, r&d and quality representatives to provide consultation on the impact of proposed changes to product, processes and the quality system.
• The role includes reviewing and sign-off on product and manufacturing changes for compliance with applicable regulations
• An effective team leader, fully motivated to achieve and demonstrate best practices in line with the goals of the regulatory department.
• The specialist will maintain and enhance cross-functional team relationships.
• The role requires review of applicable corporate sops for effect on local regulatory processes and systems.
• The Regulatory Affairs Specialist will provide input, review and approve artwork for labeling and instructions for use.
• The role involves participation in regulatory body audits, such as fda, competent authorities and notified bodies.
• Liaise and provide support to regulatory colleagues in the international markets.
• Demonstrate and actively promote highest level of professional regulatory discipline.
• Liaise with both middle and senior management on any regulatory issues relating to their area.

• A level 8 bachelor's degree in stem (regulatory affairs or relevant discipline).
• Minimum of 7 years experience in regulatory affairs or a related discipline (e.g. quality, r&d, post market) within the medical device industry.
• Demonstrated proficiency with relevant us/eu regulatory requirements for medical devices including quality systems standards.
• Prior experience with a variety of regulatory submissions for us and eu mdr.
• Adaptable and able to work independently with minimal supervision in a fast-changing environment.
• Demonstrated leadership, strategic thinking, project planning, and project management skills.
• Excellent oral/written communicator with ability to articulate ideas, transfer knowledge efficiently and effectively, influence and engage colleagues.
• Experience working in complex matrixed organizational structures with demonstrated capability to collaborate and influence across such an organization.
• Ability to effectively lead multiple regulatory projects and priorities.
• Experience working directly with fda, notified bodies, or other regulatory agencies.
• Experience with data analytics or ai tools to identify and drive operational efficiencies is a plus.

We recognize that nurturing a diverse and inclusive workplace helps us be more innovative.
It is essential in advancing science for life and improving patient health.
We stand for inclusion, equality, and opportunity for all.
By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
We are committed to providing reasonable accommodations for applicants and employees with a disability.
If you require a reasonable accommodation during the recruitment process, please email us.
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