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Smith+Nephew · 6 hours ago

Senior Regulatory Affairs Specialist

Andover, MA

Full-time

Hybrid

Senior Level

$104K/yr - $120K/yr

5+ years exp

Smith+Nephew is a company that designs and manufactures technology aimed at enhancing quality of life. The Senior Regulatory Affairs Specialist will be responsible for navigating regulatory submissions and compliance maintenance, ensuring that products meet regulatory requirements for market launch.

Medical Device

Comp. & Benefits

Responsibilities

Preparation and review of global regulatory submissions, including US 510(k) and EU technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices

Work as the RA lead on project teams independently to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines in all identified markets

Manage/lead regulatory-driven project, as directed by management

Develop and execute global regulatory strategies and support product release for market expansion activities for new and modified products

Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology

Plan, lead and support for internal and Regulatory agency audits

Lead and direct engagement with regulatory authorities as required

Initiate and manage regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impact to domestic and international product registrations, updating registrations as required to maintain regulatory submission compliance

Develop and maintain company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements

Provide technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams

Review product labeling to ensure compliance with regulatory requirements

Other activities as assigned

Qualification

Regulatory submissionsRegulatory strategiesMedical device regulationsRegulatory complianceProduct Lifecycle ManagementRAPS CertificationProject managementAnalytical problem-solvingTechnical writingInterpersonal skillsOrganizational skills

Required

Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline (RAPS Certification or RA Master's degree a plus)

Minimum of 5 years' regulatory experience or equivalent within the medical device industry or similar industries

Demonstrated experience with successful submissions in key markets such as US and EU

Demonstrated knowledge of regulatory requirements, standards and guidance for medical devices

Processes and Product Lifecycle Management Systems experience is required

Knowledge of regulatory compliance requirements (e.g. 21 CFR 820, ISO13485:2016, EU MDR, GMP etc.)

Ability to interpret and apply regulations, respond effectively to inquiries from regulatory agencies (both in writing and in person), and prepare detailed technical regulatory submissions, reports, and business correspondence

Strong interpersonal and communication skills, including technical writing, active listening, and clear verbal expression; proven ability to collaborate effectively with large cross-functional and diverse teams

Analytical and agile problem-solver with a high capacity for learning; self-motivated and solution-oriented, able to work independently and within teams, and adept at applying innovative approaches to complex challenges

Excellent organizational and time management skills, with the ability to prioritize and handle multiple demands in a dynamic, fast-paced environment