Regulatory Affairs

(Associate Director/Director)

The position will provide regulatory expertise and leadership to assure that the company meets its business objectives while complying with the regulatory framework by taking into account applicable laws, regulations and guidance documents. The incumbent will be responsible for informing regulatory strategies, overseeing the filing of necessary applications, leading and positively impacting government interactions pertaining to the regulation process for products requiring governmental approval, and for collaborating with internal staff and external resources associated with these activities.

Key Responsibilities:

• Inform regulatory strategies, in conjunction with business objectives, and translate plans into operational deliverables (i.e. submissions); advise company on regulatory issues concerning products and operations; manage regulatory activities in respect to quality and timeliness.
• Drive positive interactions with health authorities, and oversee the preparation for meetings mainly with CDRH and CFSAN as required.
• Build the framework for 510k application and support authoring relevant sections and narrative of filings, including technical narratives.
• Partner with internal departments of the company to assure development plans align with regulatory requirements, guidelines and precedence; co-develops program plans with project teams to ensure regulatory acceptability for registration purposes; ensures interaction with other disciplines to review and finalize reports and other documents.
• Represents Regulatory Affairs on project sub-teams and provide regulatory guidance to project teams on design & test documents (e.g. protocol reviews, report reviews, development plans).
• Interpret and apply applicable laws, regulations and guidelines governing devices and food products to meet business objectives.
• Assure timely continuity of company product registrations renewals.
• Review and approve the development of product labels and labeling, particularly ‘Instruction for Use’ documents, package labels, sales and marketing literature and presentation reviews/approvals.
• In addition, web-based marketing claims for compliance with applicable regulatory requirements, including development of necessary written procedures (PRC).
• Works with third party contract manufacturers towards design transfer, and to improve quality through pre-qualification reviews and on-going oversight and audits.
• In conjunction with Quality team supports post-market regulatory compliance activities such as complaint handling, MDR, adverse event reporting, recall execution and reporting.
• Serve as a key advisor to project teams with regard to Regulatory Affairs issues and procedures, particularly to ensure programs are developed to have a high degree of regulatory success through complex technical understanding and perspective.
• Develop policies and procedures to ensure regulatory compliance; may review and provide assessment of potential licensing acquisitions relative to regulatory implications and limitations; may participate in company advisory boards, attend congress and professional meetings.

Education and Experience:

• B.S. or B.A. or an equivalent combination of education and experience.
• 5+ years Regulatory Affairs experience with technical chemistry or analytical lab experience desired.
• Experience with US (Class II or higher) device clearance; Health Canada medical device (Class II or higher) license approvals; EU medical device (Class llb or higher) CE-marking a plus.
• Prior experience in worldwide post market surveillance reporting required.
• Experience in prioritizing and exercising sound judgment in RA matters is required.
• Must have analytical skills, be detail oriented and have good interpersonal skills.
• Flexible and able to work in a fast paced environment.

Key Skills and Competencies:

• Knowledge: Familiar with a variety of pharmaceutical concepts, practices, and procedures including:  21 CFR 50,54,56,200,201,202,207,312,314, and ICH; ex-US advice and registration procedures;  21 CFR800 and 510 (k) process, and proven track record of handling complex PMAs, IDEs and CE marking process for bio-medical devices.  In addition, interpretation of chemistry assays used for hydrolysis, GCMS, LCMS, USP methods, etc., is highly desirable.
• Skills: Strategic skills in interpreting applicable laws; strong organizational skills; excellent written and verbal communication, negotiation/persuasion skills, and strong interpersonal skills; detailed oriented. Ability to apply complex science to program/development needs, and to understand precedence and apply to development programs. Additional skills include; Knowledge of FDA, ISO 13485, regulations and guidelines, a must have; knowledge of toxicological assessments and capable of conducting literature reviews.
• Abilities: Use good judgment to plan, articulate positions, apply critical thinking towards achieving goals and when interacting with regulators; able to lead and collaborate with others; be flexible; ability to negotiate and persuade internal partners and regulatory agencies.

Additional Requirements:

• Travel <10%.
• Location - Waltham, Massachusetts.