Regulatory Affairs Manager

Regulatory Affairs Manager

The Regulatory Affairs Manager supports BioWave's current design and development activities for new products and leads regulatory strategy and execution for product lifecycle activities. This role is responsible for driving the MDR transition of legacy MDD devices, supporting preparation and maintenance of technical documentation, and managing U.S. and international registrations, including FDA 510(k) submissions and ex-U.S. market registrations. The position partners cross-functionally with R&D, Quality, Clinical, Manufacturing, and Commercial teams to ensure regulatory requirements are integrated into development, change management, and market access activities and may serve as, or directly support, the Person Responsible for Regulatory Compliance (PRRC) in accordance with EU MDR Article 15.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following satisfactorily (other duties may be assigned). Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Develop and execute regulatory strategies to support current design and development activities for new products from concept through commercialization.
• Provide regulatory guidance to cross-functional teams on product classification, applicable standards, testing requirements, clinical evidence expectations, labeling, and design control deliverables.
• Lead preparation, review, compilation, submission, and maintenance of regulatory dossiers and technical documentation for U.S. and international markets, including FDA 510(k) submissions and ex-U.S. registrations.
• Drive the transition of legacy MDD devices to EU MDR, including gap assessments, remediation plans, technical documentation updates, clinical evaluation support, and notified body submission readiness.
• When designated or delegated, fulfill PRRC responsibilities under EU MDR Article 15, including ensuring the conformity of applicable devices is appropriately checked in accordance with the quality management system before device release.
• Ensure technical documentation and EU declarations of conformity are prepared, reviewed, approved as applicable, and maintained current to support MDR compliance and legacy device transition activities.
• Provide regulatory oversight for post-market surveillance and vigilance processes to help ensure applicable MDR reporting obligations, including serious incident and field safety corrective action reporting, are fulfilled in a timely and compliant manner.
• Support preparation and issuance of statements for investigational devices, where applicable, and ensure regulatory deliverables required for clinical investigations are complete and maintained.
• Prepare, review, and maintain regulatory documentation such as intended use, device classification rationale, substantial equivalence content, declarations, essential requirements or GSPR evidence, and registration records.
• Assess proposed design, manufacturing, supplier, labeling, and process changes for regulatory impact and define submission or notification requirements.
• Serve as the regulatory representative in design reviews, risk management activities, change control, and project core teams to ensure regulatory requirements are embedded throughout product development.
• Coordinate communications with FDA, notified bodies, competent authorities, and international registration partners, support responses to questions, deficiencies, and requests for additional information.
• Maintain regulatory intelligence on applicable regulations, guidance, and standards and translate changes into practical actions for BioWave programs and processes.
• Support audits and inspections as the regulatory subject matter expert and ensure regulatory records are accurate, traceable, current, and inspection-ready.
• Contribute to the development and continuous improvement of regulatory procedures, templates, and internal training to strengthen submission quality and compliance execution.
• Additional responsibilities as required by management.

Competencies: To perform the job successfully, an individual should demonstrate the following competencies.

• Achievement focus demonstrates persistence and overcomes obstacles. Measures self against the standard of excellence. Recognizes and acts on opportunities. Sets and achieves challenging goals. Takes calculated risks to accomplish goals.
• Business Ethics Inspires the trust of others. Keeps commitments. Treats people with respect. Upholds organizational values. Works with integrity and ethically.
• Communications exhibits good listening and comprehension. Expresses ideas and thoughts in written form. Expresses ideas and thoughts verbally. Keeps others adequately informed. Select and use appropriate communication methods.
• Quality Management Foster's quality focus on others. Improves processes, products, and services. Measures key outcomes. Sets clear quality requirements. Solicits and applies customer feedback.
• Teamwork balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to other views Gives and welcomes feedback. Puts success of team above own interests.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:

Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Biomedical Sciences, or a related discipline required, advanced degree preferred.

Minimum 5-8 years of regulatory affairs experience in the medical device industry, including support of design and development activities, FDA 510(k) submissions, EU MDR or legacy MDD-to-MDR transition activities, and international product registrations. Experience working within ISO 13485-regulated environments and with technical documentation, design controls, risk management, change assessment, and post-market regulatory obligations is required. Experience sufficient to support or fulfill PRRC responsibilities under EU MDR Article 15 is strongly preferred.

Strong working knowledge of applicable medical device regulations and standards is required, including FDA medical device requirements, 21 CFR Part 820/QMSR concepts, 510(k) processes, EU MDR requirements, ISO 13485, and ISO 14971. Experience with notified body interactions, international registrations, post-market surveillance, vigilance reporting, and the responsibilities associated with the Person Responsible for Regulatory Compliance (PRRC) under EU MDR Article 15 is preferred.

Language Ability:

Read, analyze and interpret scientific and technical journals, financial reports and legal documents. Respond to inquiries or complaints from customers, agencies or members of the business community. Write speeches and articles for publication. Working knowledge of/Fluency in the English language (spoken and written).

Mathematical Ability:

Apply advanced concepts such as exponents, logarithms, quadratic equations and permutations. Apply operations to such tasks as frequency distribution, test reliability/validity, variance analysis, correlation technique, sampling theory and factor analysis.

Reasoning Ability:

Define problems, collect data, establish facts and draw valid conclusions. Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

To perform this job successfully, an individual should have knowledge of regulatory documentation systems, quality management systems, and standard business software.

• Advanced use of Microsoft Office applications (e.g., Word, Excel, PowerPoint, Outlook).
• Experience with electronic quality management systems, document management systems, and regulatory submission or registration tracking tools preferred.

Certificates and Licenses:

• Non-required.
• Regulatory Affairs Certification (RAC) and/or certified auditor credential preferred.

Supervisory Responsibilities : N/A

Work Environment : The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

No hazardous or significantly unpleasant conditions. Standard office environment and/or remote work.

Physical Demands : The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

Pay & Benefits Summary

• Base Salary: $100,000 - $110,000
• Medical, Vision, Dental Insurance Available
• 401K-discretionary2.5%employermatch
• Basic/Voluntary Term Life Insurance
• LongTermDisability
• HSAAccounts
• PTOYears 1and2,15days,Year3onwards20days