Purpose of Position:
Regulatory Affairs Specialist provides necessary support to regulatory affairs department in many areas including new product review, regulatory filings, promotional material review, label review, knowledge of regulations, standards or regulator guidance, response to regulators for inspection findings or submission questions, regulatory policies and procedures, customer enquiries, Product Stewardship including conflict minerals reporting, export/import requirements, post market review & assessment and training.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures (depending on training: under supervision of regulatory affairs management).
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Prepare or maintain technical files as necessary to obtain and sustain product approval (depending on training: under supervision of regulatory affairs management).
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Write or update standard operating procedures, work instructions, or policies.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues (depending on training: under supervision of regulatory affairs management).
- Compile and maintain regulatory documentation databases or systems.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Participate in internal or external audits.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Develop and/or conduct employee regulatory training.
- Review clinical protocols to ensure collection of data needed for regulatory submissions (depending on training: under supervision of regulatory affairs management).
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
- Analyze product complaints and make recommendations regarding their report ability.
- Develop or track quality metrics.
- Coordinate recall or market withdrawal activities as necessary.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
- Review product post market data and file all related reports in accordance with regulatory agency guidelines.
- Maintain facility FDA registrations and update as required.
- Maintain ongoing data set of FDA registered medical device product sku’s.
- Some Travel will be required which could include international. Position will be based out of Tewksbury MA
- This position has no direct reports.
Knowledge, Skills, and Abilities:
- Ability to work across matrix organizations.
- Excellent communication and organization skills required.
- Strong attention to detail and analytical/problem-solving skills.
- Ability to analyze, assess, and critically evaluate products and markets, and advises business teams on regulatory options.
- Demonstrable Project management skills.
- Attention to detail